HealthyPhase 1NCT02821910

Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets

A Phase 1 study testing High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed, 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR and High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted 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 purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin \& metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously. 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?: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed, 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR and High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteGermany
Study dates: 20 Jul 2016to 31 Oct 2016
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 or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
Age of 18 to 55 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device Sexually abstinent A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) Surgically sterilised (including hysterectomy) Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone above 40 U/L and estradiol below 30 ng/L is confirmatory)

Who cannot join

Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Relative Bioavailability of Two FDC Tablet Strengths of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin and Metformin Extended Release Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

Conditions: Healthy
Being tested: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed, 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR, High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted, Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed

What participants receive

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

High dose FDC Empagliflozin/Linagliptin/Metformin XR, fedDrug
High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XRDrug
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
High dose FDC Empagliflozin/Linagliptin/Metformin XR, fastedDrug
High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XRDrug
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fedDrug
Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XRDrug
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Study groups in NCT02821910
Study group	Role	What they receive
High dose, fed	Experimental	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions Receives: Drug: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed; Drug: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
High dose, fasted	Experimental	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions Receives: Drug: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted; Drug: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
Low dose, fed	Experimental	1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions Receives: Drug: Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed; Drug: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR

What is being measured

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

Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented.
Plasma concentrations and/or parameters of a subject were considered as non-evaluable, if for example
- The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subject's experiencing emesis)
- A pre-dose concentration was >5% of the Cmax value measured in that subject
- Missing samples or concentration data at important phases of PK disposition curve
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Maximum Measured Concentration of Empagliflozin in Plasma (Cmax)
Maximum measured concentration of Empagliflozin in plasma (Cmax) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Maximum Measured Concentration of Metformin in Plasma (Cmax)
Maximum measured concentration of Metformin in plasma (Cmax) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
Maximum measured concentration of Linagliptin in plasma (Cmax) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 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 (AUC0-72) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration

Secondary outcomes (3)

Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the Linagliptin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented
Measured: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration

Timeline

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

20 Jul 201631 Oct 2016

First posted4 Jul 2016 (estimated)
Study start20 Jul 2016
Primary completion1 Oct 2016
Study completion31 Oct 2016

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.
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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02821910
Sponsor's protocol ID: 1361.1
Other IDs: 2015-005082-23, 2015
Status last verified: Feb 2020
First submitted: 30 Jun 2016
Last updated: 5 Mar 2020
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Two FDC Tablet Strengths of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin and Metformin Extended Release Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)
ClinicalTrials.gov ID: NCT02821910
Acronym / sponsor ID: 1361.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 20 Jul 2016 (actual)
Primary completion: 1 Oct 2016 (actual)
Study completion: 31 Oct 2016 (actual)
First posted: 4 Jul 2016 (estimated)
Results: Posted 21 Feb 2020

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: 3

Arm	Type	Receives
High dose, fed	Experimental	Drug: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed, Drug: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions
High dose, fasted	Experimental	Drug: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted, Drug: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions
Low dose, fed	Experimental	Drug: Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed, Drug: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions

Who may qualify

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

Key inclusion criteria (6 listed)

Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
Age of 18 to 55 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

Key exclusion criteria (8 listed)

Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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
High dose FDC Empagliflozin/Linagliptin/Metformin XR, fedHigh dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet	Drug	High dose, fed
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets	Drug	High dose, fed
High dose FDC Empagliflozin/Linagliptin/Metformin XR, fastedHigh dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet	Drug	High dose, fasted
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets	Drug	High dose, fasted
Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fedLow dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet	Drug	Low dose, fed
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets	Drug	Low dose, fed

Primary outcome

Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented. Plasma concentrations and/or parameters of a subject were considered as non-evaluable, if for example * The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subject's experiencing emesis) * A pre-dose concentration was >5% of the Cmax value measured in that subject * Missing samples or concentration data at important phases of PK disposition curve
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented
Maximum Measured Concentration of Empagliflozin in Plasma (Cmax)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Maximum measured concentration of Empagliflozin in plasma (Cmax) is presented
Maximum Measured Concentration of Metformin in Plasma (Cmax)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Maximum measured concentration of Metformin in plasma (Cmax) is presented
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Maximum measured concentration of Linagliptin in plasma (Cmax) is presented
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72) is presented

3 secondary outcomes

Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration

Results and safety

Results posted to the registry on 21 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1)	7	6
E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1)	8	8
FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2)	10	8
E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2)	10	10
FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3)	7	7
E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3)	8	7

Primary outcome: Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)

Time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nanomoles (nmol)*hours (h)/litres (L)

Measure	FDC 25 Fed (T1) n = 15	E25+L5+M1000 Fed (R1) n = 14	FDC 25 Fast (T2) n = 20	E25+L5+M1000 Fast (R2) n = 18	FDC 10 Fed (T3) n = 14	E10+L5+M1000 Fed (R3) n = 15
Value	5990 (25.6)	6120 (22.8)	6430 (20.2)	6250 (18.7)	2080 (15.4)	2130 (15.5)

FDC 25 Fed (T1) vs E25+L5+M1000 Fed (R1): ratio (%): 96.70 (90% CI 92.89 to 100.66)
FDC 25 Fast (T2) vs E25+L5+M1000 Fast (R2): ratio (%): 100.80 (90% CI 97.99 to 103.70)
FDC 10 Fed (T3) vs E10+L5+M1000 Fed (R3): ratio (%): 99.83 (90% CI 95.96 to 103.85)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects in the TS who provided at least 1 primary or secondary PK parameter that was not excluded according to the criterion's for non-evaluable above.

Primary outcome: Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)

Measure	FDC 25 Fed (T1) n = 15	E25+L5+M1000 Fed (R1) n = 14	FDC 25 Fast (T2) n = 20	E25+L5+M1000 Fast (R2) n = 18	FDC 10 Fed (T3) n = 14	E10+L5+M1000 Fed (R3) n = 15
Value	13900 (29.6)	13900 (30.9)	7920 (31.3)	8260 (33.4)	12000 (26.0)	12200 (25.9)

FDC 25 Fed (T1) vs E25+L5+M1000 Fed (R1): ratio (%): 96.82 (90% CI 90.65 to 103.42)
FDC 25 Fast (T2) vs E25+L5+M1000 Fast (R2): ratio (%): 95.67 (90% CI 87.44 to 104.68)
FDC 10 Fed (T3) vs E10+L5+M1000 Fed (R3): ratio (%): 98.47 (90% CI 92.12 to 105.25)

Population analysed: PKS

Primary outcome: Maximum Measured Concentration of Empagliflozin in Plasma (Cmax)

Measure	FDC 25 Fed (T1) n = 15	E25+L5+M1000 Fed (R1) n = 14	FDC 25 Fast (T2) n = 20	E25+L5+M1000 Fast (R2) n = 18	FDC 10 Fed (T3) n = 14	E10+L5+M1000 Fed (R3) n = 15
Value	594 (17.7)	630 (20.4)	872 (24.5)	817 (31.5)	232 (20.5)	235 (18.8)

FDC 25 Fed (T1) vs E25+L5+M1000 Fed (R1): ratio (%): 94.94 (90% CI 86.60 to 104.08)
FDC 25 Fast (T2) vs E25+L5+M1000 Fast (R2): ratio (%): 106.63 (90% CI 100.65 to 112.96)
FDC 10 Fed (T3) vs E10+L5+M1000 Fed (R3): ratio (%): 100.41 (90% CI 94.54 to 106.64)

Population analysed: PKS

Primary outcome: Maximum Measured Concentration of Metformin in Plasma (Cmax)

Measure	FDC 25 Fed (T1) n = 15	E25+L5+M1000 Fed (R1) n = 14	FDC 25 Fast (T2) n = 20	E25+L5+M1000 Fast (R2) n = 18	FDC 10 Fed (T3) n = 14	E10+L5+M1000 Fed (R3) n = 15
Value	1290 (25.0)	1300 (21.4)	1010 (31.1)	1020 (32.8)	1170 (33.3)	1150 (32.6)

FDC 25 Fed (T1) vs E25+L5+M1000 Fed (R1): ratio (%): 97.97 (90% CI 91.46 to 104.94)
FDC 25 Fast (T2) vs E25+L5+M1000 Fast (R2): ratio (%): 100.04 (90% CI 90.23 to 110.91)
FDC 10 Fed (T3) vs E10+L5+M1000 Fed (R3): ratio (%): 101.24 (90% CI 94.58 to 108.38)

Population analysed: PKS

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FDC 25 Fed (T1)	0 of 15 (0%)	5 of 15 (33.3%)	Not reported
E25+L5+M1000 Fed (R1)	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
FDC 25 Fast (T2)	0 of 20 (0%)	6 of 20 (30%)	Not reported
E25+L5+M1000 Fast (R2)	0 of 18 (0%)	4 of 18 (22.2%)	Not reported
FDC 10 Fed (T3)	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
E10+L5+M1000 Fed (R3)	0 of 15 (0%)	4 of 15 (26.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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?

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 6 inclusion and 8 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 5 Mar 2020. 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 21 Feb 2020). 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?

Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) (time frame: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration). The study lists 6 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 NCT02821910.

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 5 Mar 2020.