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NCT01975220 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01975220: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT01975220 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01975220, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.
Primary Outcome
Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin
Interventions
- DRUG 1 tablet Empagliflozin/2 tablets Metformin XR
- DRUG Empagliflozin/Metformin XR, FDC
- DRUG Empagliflozin/Metformin XR FDC
- DRUG 25 mg Empagliflozin/1000 mg Metformin XR, FDC
- DRUG 1 tablet Empagliflozin/3 tablets Metformin XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2013-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01975220 record still lists
NCT01975220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 5 interventions - of which 1 tablet Empagliflozin/2 tablets Metformin XR is the first listed.
NCT01975220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01975220 about?
NCT01975220 is a clinical study titled "Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets". The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.
What is the current status of trial NCT01975220?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2013-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01975220?
The interventions under investigation include: 1 tablet Empagliflozin/2 tablets Metformin XR (DRUG), Empagliflozin/Metformin XR, FDC (DRUG), Empagliflozin/Metformin XR FDC (DRUG), 25 mg Empagliflozin/1000 mg Metformin XR, FDC (DRUG), 1 tablet Empagliflozin/3 tablets Metformin XR (DRUG).
Who is sponsoring clinical trial NCT01975220?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01975220's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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