HealthyPhase 1NCT01242176

Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers

A Phase 1 study testing BI 10773 XX (Trial Formulation 2) and BI 10773 (Final Formulation) 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

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Trial summary

The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2). 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 XX (Trial Formulation 2) and BI 10773 (Final Formulation)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteGermany
Study dates: Nov 2010to Dec 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

1245.51.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Relative Bioavailability of 25 mg BI 10773 (Final Formulation) Compared to 25 mg BI 10773 XX (Trial Formulation 2) Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

Conditions: Healthy
Being tested: BI 10773 XX (Trial Formulation 2), BI 10773 (Final Formulation)

What participants receive

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

BI 10773 XX (Trial Formulation 2)Drug
one single dose tablet in the morning
BI 10773 (Final Formulation)Drug
one single film-coated tablet in the morning

Study groups in NCT01242176
Study group	Role	What they receive
BI 10773 Final Formulation	Experimental	one single film-coated tablet in the morning Receives: Drug: BI 10773 (Final Formulation)
BI 10773 XX Trial Formulation 2	Experimental	one single dose tablet in the morning Receives: Drug: BI 10773 XX (Trial Formulation 2)

What is being measured

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

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.
Note the standard deviation is actually the coefficient of variation (CV (%)).
Measured: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma.
Note the standard deviation is actually the CV (%).
Measured: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Secondary outcomes (1)

Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.
Note the standard deviation is actually the CV (%).
Measured: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 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.

Nov 2010Dec 2010

First posted16 Nov 2010 (estimated)
Study startNov 2010
Primary completionDec 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.
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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01242176
Sponsor's protocol ID: 1245.51
Other IDs: 2010-022469-81
Status last verified: May 2014
First submitted: 10 Nov 2010
Last updated: 18 Jun 2014
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

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of 25 mg BI 10773 (Final Formulation) Compared to 25 mg BI 10773 XX (Trial Formulation 2) Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
ClinicalTrials.gov ID: NCT01242176
Acronym / sponsor ID: 1245.51
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Dec 2010 (actual)
First posted: 16 Nov 2010 (estimated)
Results: Posted 18 Jun 2014

Clinical summary

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

The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI 10773 Final Formulation	Experimental	Drug: BI 10773 (Final Formulation)one single film-coated tablet in the morning
BI 10773 XX Trial Formulation 2	Experimental	Drug: BI 10773 XX (Trial Formulation 2)one single dose tablet in the morning

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 XX (Trial Formulation 2)one single dose tablet in the morning	Drug	BI 10773 XX Trial Formulation 2
BI 10773 (Final Formulation)one single film-coated tablet in the morning	Drug	BI 10773 Final Formulation

Primary outcome

Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 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 extrapolated to infinity. Note the standard deviation is actually the coefficient of variation (CV (%)).
Maximum Measured Concentration (Cmax)
Time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 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. Note the standard deviation is actually the CV (%).

1 secondary outcome

Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Results and safety

Results posted to the registry on 18 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empa FF / Empa TF2	12	12
Empa TF2 / Empa FF	12	12

Primary outcome: Area Under the Curve 0 to Infinity (AUC0-∞)

Time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration. Mean (Standard Deviation). Unit: nmol*h/L

Measure	Empa FF n = 21	Empa TF2 n = 23
Value	5200 (20.7)	5090 (17.7)

Empa FF vs Empa TF2: Geometric Mean Ratio: 101.67 (90% CI 98.10 to 105.37), ANOVA

Population analysed: Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.

Primary outcome: Maximum Measured Concentration (Cmax)

Measure	Empa FF n = 21	Empa TF2 n = 23
Value	764 (26.5)	764 (23.0)

Empa FF vs Empa TF2: Geometric Mean Ratio: 99.46 (90% CI 90.18 to 109.68), ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From drug administration until end of study visit, up to 10 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa FF	0 of 22 (0%)	1 of 22 (4.5%)	Not reported
Empa TF2	1 of 23 (4.3%)	4 of 23 (17.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 XX (Trial Formulation 2) and BI 10773 (Final Formulation) 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 18 Jun 2014. 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 18 Jun 2014). 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 Curve 0 to Infinity (AUC0-∞) (time frame: 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration). The study lists 2 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 NCT01242176.

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 18 Jun 2014.