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A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

NCT02073227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-09-09

No results posted yet for this study

Summary

The purpose of this study is to assess the bioequivalence 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/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Canagliflozin, 300 mg

Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth).

DRUG

Metformin XR, 500 mg

Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).

DRUG

CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg

Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.

DRUG

CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg

Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073227 on ClinicalTrials.gov