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NCT02073227 · 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 of Healthy Volunteers, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT02073227: Completed Phase 1 study of Healthy Volunteers, sponsored by Janssen Research & Development.
NCT02073227 is a Phase 1 study of Healthy Volunteers that has completed, run by Janssen Research & Development. The registered enrollment target is 52 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02073227, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
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 150 mg/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 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.
Conditions Studied
Interventions
- DRUG Canagliflozin, 300 mg
- DRUG Metformin XR, 500 mg
- DRUG CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg
- DRUG CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg
Study Locations (1)
Arizona
- - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT02073227 record still lists
NCT02073227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which Canagliflozin, 300 mg is the first listed.
NCT02073227 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT02073227 about?
NCT02073227 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 150 mg/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metfor...
What is the current status of trial NCT02073227?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2014-02. Estimated completion is 2014-06.
What conditions does trial NCT02073227 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT02073227?
The interventions under investigation include: Canagliflozin, 300 mg (DRUG), Metformin XR, 500 mg (DRUG), CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg (DRUG), CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg (DRUG).
Who is sponsoring clinical trial NCT02073227?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02073227 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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Where NCT02073227's enrollment target sits among peer trials
52 134th of 283 higher than 149 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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