A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

NCT02065752 | Completed Phase 1 DMC

• 2 other identifiers: CR10325428431754DIA1041
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/500 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Canagliflozin; Metformin; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Plasma concentration of canagliflozin following the single dose of drug administration

  Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.

  Predose, (before tablet intake) up to 72 hours afterdose

• Plasma concentration of metformin following the single dose of drug administration

  Plasma concentrations of metformin are used to evaluate how long it stays in the body.

  Predose, up to 36 hours afterdose

Secondary Outcomes (1)

• Percentage of participants with adverse events as a measure of safety and tolerability

  Screening, up to Day 10 of the follow-up period

Study Arms (3)

Treatment A

EXPERIMENTAL

Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 100 mg, and 2 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.

Drug: Canagliflozin, 100 mg; Drug: Metformin XR, 500 mg

Treatment B

EXPERIMENTAL

Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions.

Drug: CANA/MET XR FDC, Formulation 1, 50 mg/500 mg

Treatment C

EXPERIMENTAL

Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions.

Drug: CANA/MET XR FDC, Formulation 2, 50 mg/500 mg

Interventions

Canagliflozin, 100 mg DRUG

Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).

Treatment A

Metformin XR, 500 mg DRUG

Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).

Also known as: GLUMETZA®

Treatment A

CANA/MET XR FDC, Formulation 1, 50 mg/500 mg DRUG

Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.

Treatment B

CANA/MET XR FDC, Formulation 2, 50 mg/500 mg DRUG

Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.

Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 drugs or lactose
• Known allergy to heparin or history of heparin induced thrombocytopenia
• Donated blood or blood products or had substantial loss of blood within 3 months before screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 19, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

US (1)