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NCT02071368 · 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
- 3
- Enrollment target
NCT02071368 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 3 participants.
The verdict
NCT02071368, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 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 150 mg/500mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.
Interventions
- DRUG Canagliflozin, 300 mg
- DRUG Metformin XR, 500 mg
- DRUG CANA/MET XR FDC, Formulation 1, 150 mg/500
- DRUG CANA/MET XR FDC, Formulation 2, 150 mg/500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02071368
The ClinicalTrials.gov registry entry for NCT02071368 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Canagliflozin, 300 mg is the first listed.
NCT02071368 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02071368 about?
NCT02071368 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 150 mg/500mg) with respect to the i...
What is the current status of trial NCT02071368?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-02. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02071368?
The interventions under investigation include: Canagliflozin, 300 mg (DRUG), Metformin XR, 500 mg (DRUG), CANA/MET XR FDC, Formulation 1, 150 mg/500 (DRUG), CANA/MET XR FDC, Formulation 2, 150 mg/500 mg (DRUG).
Who is sponsoring clinical trial NCT02071368?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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