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NCT02106923 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT02106923: Completed Phase 1 study, sponsored by Boehringer Ingelheim.

NCT02106923 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.

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The verdict

NCT02106923, 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 combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly

Primary Outcome

Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

Interventions

  • DRUG 1 tablet Empagliflozin/2 tablets Metformin XR
  • DRUG 10 mg Empagliflozin/1000 mg Metformin XR
  • DRUG 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR
  • DRUG 2 tablets 5 mg Empagliflozin/750 Metformin XR

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2014-04
Est. Completion 2014-07
Phase Phase 1
Boehringer Ingelheim

515 total trials

What the finished NCT02106923 record still lists

NCT02106923 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 4 interventions - of which 1 tablet Empagliflozin/2 tablets Metformin XR is the first listed.

NCT02106923 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02106923 about?

NCT02106923 is a clinical study titled "Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets". The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly

What is the current status of trial NCT02106923?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2014-04. Estimated completion is 2014-07.

What interventions are being tested in trial NCT02106923?

The interventions under investigation include: 1 tablet Empagliflozin/2 tablets Metformin XR (DRUG), 10 mg Empagliflozin/1000 mg Metformin XR (DRUG), 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR (DRUG), 2 tablets 5 mg Empagliflozin/750 Metformin XR (DRUG).

Who is sponsoring clinical trial NCT02106923?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02106923'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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Source: ClinicalTrials.gov NCT02106923, the US trial registry maintained by the National Library of Medicine. NCT02106923 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.