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NCT01454622 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT01454622: Completed Phase 1 study of Healthy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT01454622 is a Phase 1 study of Healthy that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 64 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01454622, a Phase 1 study of Healthy, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
Conditions Studied
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)
Study Locations (1)
Arizona
- - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01454622 record still lists
NCT01454622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets) is the first listed.
NCT01454622 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01454622 about?
NCT01454622 is a clinical study titled "A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers". The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets 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 NCT01454622?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2011-09. Estimated completion is 2011-11.
What conditions does trial NCT01454622 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01454622?
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 NCT01454622?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01454622 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01454622's enrollment target sits among peer trials
64 353rd of 1090 higher than 731 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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