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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02851095
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC] — DRUG
    Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 1000 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
  • Canagliflozin — DRUG
    Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
  • Metformin Extended Release (XR) — DRUG
    Participants will receive 2 metformin XR tablets of each 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.

Study Details

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) tablets co-administered with canagliflozin in healthy fed and fasted participants.

Key Dates

Start date
Aug 31, 2016
Status verified
Jan 2025
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment Sequence ADBC
    Participants will receive Treatment A (1 canagliflozin tablet 50 milligram (mg) along with two Extended Release (XR) tablet of metformin of each 500 mg orally under fed condition) on Day 1 of treatment period 1, then Treatment D of (1 XR fixed dose combination \[FDC\] tablet containing canagliflozin 50 mg and metformin 1000 mg orally under fasted condition) on Day 1 of treatment period 2, then Treatment B (1 XR FDC tablet containing canagliflozin 50 mg and 1 metformin 1000 mg orally under fed condition) on Day 1 of treatment period 3, followed by Treatment C (1 canagliflozin tablet 50 mg along with 2 metformin (XR) tablets of each 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
  • Experimental: Treatment Sequence BACD
    Participants will receive Treatment B on Day 1 of treatment period 1, then Treatment A on Day 1 of treatment period 2, then Treatment C on Day 1 of treatment period 3, followed by Treatment D on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
  • Experimental: Treatment Sequence CBDA
    Participants will receive Treatment C Day 1 of treatment period 1, then Treatment B on Day 1 of treatment period 2, then Treatment D on Day 1 of treatment period 3, followed by Treatment A on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.
  • Experimental: Treatment Sequence DCAB
    Participants will receive Treatment D on Day 1 of treatment period 1, then Treatment C on Day 1 of treatment period 2, then Treatment A on Day 1 of treatment period 3, followed by Treatment B on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Metformin [ Time Frame: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-LincolnNebraska--

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