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NCT02077803 · 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
- 47
- Enrollment target
NCT02077803 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 47 participants.
The verdict
NCT02077803, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 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 50 mg/1000 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.
Interventions
- DRUG Metformin XR, 500 mg
- DRUG Canagliflozin, 100 mg
- DRUG CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg
- DRUG CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02077803
The ClinicalTrials.gov registry entry for NCT02077803 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 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 Metformin XR, 500 mg is the first listed.
NCT02077803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02077803 about?
NCT02077803 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 50 mg/1000 mg) with respect to the ...
What is the current status of trial NCT02077803?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2014-03. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02077803?
The interventions under investigation include: Metformin XR, 500 mg (DRUG), Canagliflozin, 100 mg (DRUG), CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg (DRUG), CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg (DRUG).
Who is sponsoring clinical trial NCT02077803?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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