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NCT01463228 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
83
Enrollment target

NCT01463228 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 83 participants.

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The verdict

NCT01463228, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
83 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet 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

FieldValue
Enrollment Target 83 participants
Start Date 2011-09
Est. Completion 2012-01
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT01463228

The ClinicalTrials.gov registry entry for NCT01463228 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 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 2 interventions - of which A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets) is the first listed.

NCT01463228 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01463228 about?

NCT01463228 is a clinical study titled "A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers". The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet 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 NCT01463228?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2011-09. Estimated completion is 2012-01.

What interventions are being tested in trial NCT01463228?

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 NCT01463228?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.