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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: Completed Phase 1 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 64 participants
Start Date 2011-09
Est. Completion 2011-11
Phase Phase 1

What the finished NCT01518712 record still lists

NCT01518712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01518712's enrollment target sits among peer trials

64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01518712, the US trial registry maintained by the National Library of Medicine. NCT01518712 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.