A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets; Drug: Treatment A: Metformin IR tablets; Drug: Treatment A: Canagliflozin tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463774

CR100674

28431754DIA1039 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

Full description

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Enrollment: 74 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 18.5 and 30 kg/m² 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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74 participants in 2 patient groups

Treatment Sequence AB

Experimental group

Description:

The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.

Treatment:

Drug: Treatment A: Metformin IR tablets

Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets

Drug: Treatment A: Canagliflozin tablet

Treatment Sequence BA

Experimental group

Description:

The study consists of 2 treatment periods (A and B). Each treatment period wiill be separated by a washout period of 10-15 days.

Treatment:

Drug: Treatment A: Metformin IR tablets

Drug: Treatment B: Canagliflozin/metformin fixed dose combination tablets

Drug: Treatment A: Canagliflozin tablet