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NCT01463228 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT01463228: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT01463228 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 83 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01463228, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
Interventions
- DRUG A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)
- DRUG B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01463228 record still lists
NCT01463228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets) is the first listed.
NCT01463228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01463228 about?
NCT01463228 is a clinical study titled "A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers". The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
What is the current status of trial NCT01463228?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2011-09. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01463228?
The interventions under investigation include: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets) (DRUG), B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets) (DRUG).
Who is sponsoring clinical trial NCT01463228?
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 NCT01463228's enrollment target sits among peer trials
83 665th of 2000 higher than 1,332 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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