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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC); Drug: Metformin IR; Drug: Canagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02220218

CR104979

28431754DIA1070 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

Treatment Sequence ABDC

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Drug: Canagliflozin

Drug: Metformin IR

Treatment Sequence BCAD

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Drug: Canagliflozin

Drug: Metformin IR

Treatment Sequence CDBA

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Drug: Canagliflozin

Drug: Metformin IR

Treatment Sequence DACB

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)

Drug: Canagliflozin

Drug: Metformin IR