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NCT02065752 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02065752: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02065752 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065752, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.
Primary Outcome
Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Interventions
- DRUG Metformin XR, 500 mg
- DRUG Canagliflozin, 100 mg
- DRUG CANA/MET XR FDC, Formulation 1, 50 mg/500 mg
- DRUG CANA/MET XR FDC, Formulation 2, 50 mg/500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT02065752 record still lists
NCT02065752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Metformin XR, 500 mg is the first listed.
NCT02065752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02065752 about?
NCT02065752 is a clinical study titled "A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components". The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin...
What is the current status of trial NCT02065752?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2014-02. Estimated completion is 2014-04.
What interventions are being tested in trial NCT02065752?
The interventions under investigation include: Metformin XR, 500 mg (DRUG), Canagliflozin, 100 mg (DRUG), CANA/MET XR FDC, Formulation 1, 50 mg/500 mg (DRUG), CANA/MET XR FDC, Formulation 2, 50 mg/500 mg (DRUG).
Who is sponsoring clinical trial NCT02065752?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02065752's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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