A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (150 mg/500 mg) With Respect to the Metformin XR Tablet (Locally Sourced From Canada [GLUMETZA, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 100 mg + 1 x 50 mg) in Healthy Fed and Fasted Subjects

NCT02846506 Phase 1 COMPLETED

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.

Details

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	COMPLETED
Enrolment	44
Start date	2016-08
Completion	2016-10

Conditions

• Healthy

Interventions

• Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]
• Canagliflozin 50 mg
• Canagliflozin 100 mg
• Metformin Extended Release (XR)

Primary outcomes

• Maximum Observed Plasma Concentration (Cmax) of Metformin — 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
  The Cmax is the maximum observed plasma concentration of metformin.
• Area Under the Plasma Concentration-Time Curve From Time 0 to The Time of the Last Observed Quantifiable Concentration (AUClast) of Metformin — 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
  The AUClast is the area under the plasma concentration-time curve from time 0 to the time of the last observed quantifiable concentration (Clast).
• Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time [AUC (0-infinity)] of Metformin — 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
  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Countries

United States