Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02220218

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study to evaluate the bioequivalence (is the amount same in both the pills) of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin tablet in healthy fed and fasted participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC) Drug: Canagliflozin Drug: Metformin IR	Phase 1

Detailed Description

This is a randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to volunteer and study staff), single-center, single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study group to another in a clinical trial, like the flip of a coin) study in healthy adult participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22 to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3 days each [Day -1 to Day 2], each separated by a washout period of 7 days) and Follow-up Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will be collected at pre-dose and post-dose of study treatment, for understanding the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time). Participants' safety will be monitored throughout the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 Immediate Release (IR) 1 x (50 mg/500 mg) With Respect to the Metformin IR Tablet (Locally Sourced From Canada [Glucophage, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 50 mg) in Healthy Fed and Fasted Subjects

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Sequence ABDC Treatment A (canagliflozin and metformin immediate release [IR] fixed dose combination [FDC] tablet 50 milligram [mg]/500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/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.	Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC) Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Canagliflozin Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Metformin IR Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Experimental: Treatment Sequence BCAD Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 1, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 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.	Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC) Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Canagliflozin Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Metformin IR Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Experimental: Treatment Sequence CDBA Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 2, followed by Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 3, then Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.	Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC) Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Canagliflozin Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Metformin IR Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
Experimental: Treatment Sequence DACB Treatment D (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fasted condition) on Day 1 of treatment period 1, followed by Treatment A (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed condition) on Day 1 of treatment period 2, followed by Treatment C (canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fasted condition) on Day 1 of treatment period 3, then Treatment B (canagliflozin tablet 50 mg along with metformin IR tablet 500 mg orally under fed condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period.	Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC) Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Canagliflozin Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods. Drug: Metformin IR Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.

Outcome Measures

Primary Outcome Measures

Plasma Concentration of Metformin [Pre-dose up to 24 hours post-dose]
Plasma concentrations of metformin are used to evaluate how much metformin is in the blood over time.
Plasma Concentration of Canagliflozin [2 hours after dosing]
Plasma concentrations of canagliflozin are used to evaluate how much canagliflozin is in the blood, 2 hours after dosing.

Secondary Outcome Measures

Adverse Events [Up to approximately 58 days]
The number and type of adverse events will be reported from Day 1 of treatment period 1 through 5-7 days after treatment period 4 including a 7+/- 1 day washout period between treatment periods (total time is approximately 58 days).
Clinical Laboratory Tests [Up to approximately 58 days]
Clinically relevant changes occurring in laboratory safety parameters will be evaluated.
Vital Signs [Up to approximately 58 days]
Blood pressure, pulse, and oral body temperature will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Body mass index (BMI) between 18.5 and 30 kilogram per square meter (kg/m^2) (inclusive) and a body weight of not less than 50 kg

Exclusion Criteria:

History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator