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NCT02077803 · 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 in Healthy Fed Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT02077803: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02077803 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02077803, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) 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/1000 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (4 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/1000 mg
- DRUG CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT02077803 record still lists
NCT02077803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Metformin XR, 500 mg is the first listed.
NCT02077803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02077803 about?
NCT02077803 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 in Healthy Fed Participants". The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) 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/1000 mg) with respect to the ...
What is the current status of trial NCT02077803?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2014-03. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02077803?
The interventions under investigation include: Metformin XR, 500 mg (DRUG), Canagliflozin, 100 mg (DRUG), CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg (DRUG), CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg (DRUG).
Who is sponsoring clinical trial NCT02077803?
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 NCT02077803's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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