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NCT01518712 · 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) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers
A Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT01518712 is a Phase 1 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 64 participants.
The verdict
NCT01518712, a Phase 1 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
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.
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 | 64 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01518712
The ClinicalTrials.gov registry entry for NCT01518712 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
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.
NCT01518712 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01518712 about?
NCT01518712 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) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 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 NCT01518712?
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 interventions are being tested in trial NCT01518712?
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 NCT01518712?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
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