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A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants

NCT02846506 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet co-administered with canagliflozin in healthy fed and fasted participants.

Conditions

  • Healthy

Interventions

DRUG

Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]

Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.

DRUG

Canagliflozin 50 mg

Participants will receive canagliflozin 50 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.

DRUG

Canagliflozin 100 mg

Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.

DRUG

Metformin Extended Release (XR)

Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.

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
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-10-31
Completion
2016-10-31

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 NCT02846506 on ClinicalTrials.gov