Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: CANA/MET XR FDC

Study type

Interventional

Funder types

Industry

Identifiers

NCT02039245

28431754DIA1042 (Other Identifier)

CR103255

Details and patient eligibility

About

The purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.

Full description

This is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase, (when the participants will be confined to the study center for 11 days), and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days after a provided dinner. Participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must sign an informed consent document indicating they understand the purpose of the study and procedures
Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
Must have a body weight of not less than 50 kg
Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion criteria

History of or current clinically significant medical illness
Use of any systemic prescription or nonprescription medication (including vitamins and herbal supplements)
Known allergy to canagliflozin or metformin or any of the excipients of the formulation
Known allergy to heparin or history of heparin induced thrombocytopenia
History of smoking or use of nicotine-containing substances within the previous 2 months