HealthyPhase 1NCT01189201

Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food

A Phase 1 study testing BI 10773/linagliptin, BI 10773/linagliptin SID and BI 10773/linagliptin FDC in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 10773/linagliptin, BI 10773/linagliptin SID and BI 10773/linagliptin FDC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteGermany
Study dates: Aug 2010to Nov 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy male and female subjects

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

1275.3.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability Investigations of a 25 mg BI 10773 / 5 mg Linagliptin Fixed Dose Combination (FDC) Tablet (Formulation A1) Including the Comparison With Its Mono-components, the Comparison With a Second FDC Tablet (Formulation A3), and the Investigation of Food (an Open-label, Randomised, Single Dose, Crossover, Phase I Trial in Healthy Male and Female Volunteers)

The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison.

An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.

Conditions: Healthy
Being tested: BI 10773/linagliptin, BI 10773/linagliptin SID, BI 10773/linagliptin FDC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 10773/linagliptinDrug
medium single dose of BI 10773/linagliptin FDC (Formulation A1)
BI 10773/linagliptinDrug
medium single dose of BI 10773/linagliptin FDC (Formulation A3)
BI 10773/linagliptin SIDDrug
medium single dose of mono components BI 10773/linagliptin
BI 10773/linagliptin FDCDrug
medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal

Study groups in NCT01189201
Study group	Role	What they receive
BI 10773/linagliptin FDC SID	Experimental	medium single dose ofBI 10773/linagliptin FDC (Formulation A1) Receives: Drug: BI 10773/linagliptin
BI 10773/linagliptin SID	Experimental	medium single dose of mono components BI 10773/linagliptin Receives: Drug: BI 10773/linagliptin SID
BI 10773/linagliptin FDC	Experimental	medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal Receives: Drug: BI 10773/linagliptin FDC
BI 10773/linagliptin	Experimental	medium single dose of BI 10773/linagliptin FDC (Formulation A3) Receives: Drug: BI 10773/linagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of linagliptin in plasma.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)
Maximum measured concentration of linagliptin in plasma.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)
Maximum measured concentration of linagliptin in plasma.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Secondary outcomes (9)

Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)
Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)
Time from last dosing to the maximum measured concentration of linagliptin in plasma
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.
In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination.
Measured: Drug administration until next treatment period/end-of-study examination, up to 36 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Nov 2010

First posted26 Aug 2010 (estimated)
Study startAug 2010
Primary completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01189201
Sponsor's protocol ID: 1275.3
Other IDs: 2010-019211-38
Status last verified: Mar 2015
First submitted: 25 Aug 2010
Last updated: 19 Mar 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Glund S, Mattheus M, Runge F, Rose P, Friedrich C. Relative bioavailability of an empagliflozin 25-mg/linagliptin 5-mg fixed-dose combination tablet . Int J Clin Pharmacol Ther. 2017 Apr;55(4):355-367. doi: 10.5414/CP202929.
PubMed 28290274

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability Investigations of a 25 mg BI 10773 / 5 mg Linagliptin Fixed Dose Combination (FDC) Tablet (Formulation A1) Including the Comparison With Its Mono-components, the Comparison With a Second FDC Tablet (Formulation A3), and the Investigation of Food (an Open-label, Randomised, Single Dose, Crossover, Phase I Trial in Healthy Male and Female Volunteers)
ClinicalTrials.gov ID: NCT01189201
Acronym / sponsor ID: 1275.3
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Nov 2010 (actual)
First posted: 26 Aug 2010 (estimated)
Results: Posted 19 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
BI 10773/linagliptin FDC SID	Experimental	Drug: BI 10773/linagliptinmedium single dose ofBI 10773/linagliptin FDC (Formulation A1)
BI 10773/linagliptin SID	Experimental	Drug: BI 10773/linagliptin SIDmedium single dose of mono components BI 10773/linagliptin
BI 10773/linagliptin FDC	Experimental	Drug: BI 10773/linagliptin FDCmedium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal
BI 10773/linagliptin	Experimental	Drug: BI 10773/linagliptinmedium single dose of BI 10773/linagliptin FDC (Formulation A3)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

healthy male and female subjects

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 10773/linagliptinmedium single dose of BI 10773/linagliptin FDC (Formulation A1)	Drug	BI 10773/linagliptin FDC SID
BI 10773/linagliptinmedium single dose of BI 10773/linagliptin FDC (Formulation A3)	Drug	BI 10773/linagliptin
BI 10773/linagliptin SIDmedium single dose of mono components BI 10773/linagliptin	Drug	BI 10773/linagliptin SID
BI 10773/linagliptin FDCmedium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal	Drug	BI 10773/linagliptin FDC

Primary outcome

Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Empagliflozin: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of empagliflozin (empa) in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Linagliptin: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of empagliflozin (empa) in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

9 secondary outcomes

Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator
Time frame: Drug administration until next treatment period/end-of-study examination, up to 36 days

Results and safety

Results posted to the registry on 19 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Overall	42	41

Primary outcome: Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)

Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	Empa Plus Linagliptin FDC A1 (Fasted) n = 42	Empa Plus Linagliptin Individual Tablets (Fasted) n = 40
Value	5990 (21.0)	5720 (20.8)

Empa Plus Linagliptin FDC A1 (Fasted) vs Empa Plus Linagliptin Individual Tablets (Fasted): Geometric Mean Ratio: 104.90 (90% CI 102.07 to 107.80), ANOVA

Population analysed: Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.

Primary outcome: Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)

Measure	Empa Plus Linagliptin FDC A1 (Fasted) n = 42	Empa Plus Linagliptin Individual Tablets (Fasted) n = 40
Value	264 (22.1)	250 (22.1)

Empa Plus Linagliptin FDC A1 (Fasted) vs Empa Plus Linagliptin Individual Tablets (Fasted): Geometric Mean Ratio: 104.91 (90% CI 99.97 to 110.09), ANOVA

Primary outcome: Empagliflozin: Maximum Measured Concentration (Cmax)

Measure	Empa Plus Linagliptin FDC A1 (Fasted) n = 42	Empa Plus Linagliptin Individual Tablets (Fasted) n = 40
Value	862 (26.8)	803 (24.9)

Empa Plus Linagliptin FDC A1 (Fasted) vs Empa Plus Linagliptin Individual Tablets (Fasted): Geometric Mean Ratio: 107.68 (90% CI 101.70 to 114.02), ANOVA

Primary outcome: Linagliptin: Maximum Measured Concentration (Cmax)

Measure	Empa Plus Linagliptin FDC A1 (Fasted) n = 42	Empa Plus Linagliptin Individual Tablets (Fasted) n = 40
Value	8.19 (36.4)	7.49 (31.0)

Empa Plus Linagliptin FDC A1 (Fasted) vs Empa Plus Linagliptin Individual Tablets (Fasted): Geometric Mean Ratio: 109.68 (90% CI 99.55 to 120.83), ANOVA

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment period and following washout period, up to 36 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa Plus Linagliptin FDC A1 (Fasted)	0 of 42 (0%)	8 of 42 (19%)	Not reported
Empa Plus Linagliptin Individual Tablets (Fasted)	0 of 41 (0%)	5 of 41 (12.2%)	Not reported
Empa Plus Linagliptin FDC A1 (Fed)	0 of 18 (0%)	6 of 18 (33.3%)	Not reported
Empa Plus Linagliptin FDC A3 (Fasted)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28290274Glund S, Mattheus M, Runge F, Rose P, Friedrich C. Relative bioavailability of an empagliflozin 25-mg/linagliptin 5-mg fixed-dose combination tablet . Int J Clin Pharmacol Ther. 2017 Apr;55(4):355-367. doi: 10.5414/CP202929.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 10773/linagliptin, BI 10773/linagliptin SID and BI 10773/linagliptin FDC in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) (time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01189201, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.