Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food

NCT ID: NCT02039258

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-03-31

Brief Summary

The purpose of this study is to assess the effect of coadministration of a high-fat meal on the oral bioavailability of a fixed dose combination of Canagliflozin/extended release Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in healthy participants.

Detailed Description

This is a randomized (a sequence of fasted and fed periods accompanying study drug intake will be assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 2-period, 2-sequence, crossover study of Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg. Approximately 24 healthy adult participants will be enrolled to ensure that at least 20 complete the study.

After a screening period, participants will be randomly assigned to 1 of the 2 treatment sequences (AB or BA) on Day 1 of Period 1. Treatment A means a participant will receive a single 150/1,000 mg CANA/MET XR FDC tablet under fasted conditions, and Treatment B means that a participant will receive the same drug under fed conditions. Participants will need to remain at the study center for 4 days (72 hours postdose) after the drug administration for collection of blood samples in each treatment period. There will be a 10- to 14-day washout period between Period 1 and Period 2. On Day 4 (72 hours postdose) of Period 2, when participants are discharged from the study center, they will be given instructions to return for a follow-up visit 7 to 10 days later. For Treatment B (in fed state), participants will be provided with a standardized high-fat breakfast. Participants' safety will be monitored throughout the study.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence AB

A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fasted conditions (treatment A) followed by the same single dose under fed conditions (treatment B).

Group Type: EXPERIMENTAL

CANA/MET XR FDC

Intervention Type: DRUG

Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg

Sequence BA

A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fed conditions (treatment B) followed by the same single dose under fasted conditions (treatment A).

Group Type: EXPERIMENTAL

CANA/MET XR FDC

Intervention Type: DRUG

Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg

Interventions

CANA/MET XR FDC

Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg

Intervention Type: DRUG

Eligibility Criteria

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 prescription or nonprescription medication (including vitamins and herbal supplements)
• History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose- Known allergy to heparin or history of heparin induced thrombocytopenia
• History of smoking or use of nicotine-containing substances within the previous 2 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

28431754DIA1064

Identifier Type: OTHER

Identifier Source: secondary_id

CR103259

Identifier Type: -

Identifier Source: org_study_id