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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy Volunteers
Intervention	Drug: Canagliflozin, 100 mg Drug: Metformin XR, 500 mg Drug: CANA/MET XR FDC, Formulation 1, 50 mg/500 mg Drug: CANA/MET XR FDC, Formulation 2, 50 mg/500 mg
Phase	Phase 1
Sponsor	Janssen Research & Development, LLC
Responsible Party	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier	NCT02065752
First Received	February 17, 2014
Last Updated	April 11, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	February 17, 2014
Last Updated Date	April 11, 2014
Start Date	February 2014
Estimated Primary Completion Date	April 2014
Current Primary Outcome Measures	Plasma concentration of canagliflozin following the single dose of drug administration [Time Frame: Predose, (before tablet intake) up to 72 hours afterdose] [Designated as safety issue: No]Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body. Plasma concentration of metformin following the single dose of drug administration [Time Frame: Predose, up to 36 hours afterdose] [Designated as safety issue: No]Plasma concentrations of metformin are used to evaluate how long it stays in the body.
Current Secondary Outcome Measures	Percentage of participants with adverse events as a measure of safety and tolerability [Time Frame: Screening, up to Day 10 of the follow-up period] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
Official Title	A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (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 Subjects
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.
Detailed Description	This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets of individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets). The tablets will be of the same strength (50 mg CANA/500 mg MET XR) and will be compared with the equal doses of the individual drugs: canagliflozin (1 x 100 mg tablet) and metformin XR (2 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components. Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each (Days -1 through 4) separated by a washout of 10 to 14 days between Day 1 of each Treatment Period, and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure on Day 4 of Treatment Period 3. The total duration of the study will be about 70 days for each participant.
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy Volunteers
Intervention	Drug: Canagliflozin, 100 mg Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth). Drug: Metformin XR, 500 mg Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth). Other Names: GLUMETZA®Drug: CANA/MET XR FDC, Formulation 1, 50 mg/500 mg 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. Drug: CANA/MET XR FDC, Formulation 2, 50 mg/500 mg 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.
Study Arm (s)	Experimental: Treatment A 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. Experimental: Treatment B Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 1, under fed conditions. Experimental: Treatment C Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC, formulation 2, under fed conditions.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	42
Estimated Completion Date	April 2014
Estimated Primary Completion Date	April 2014
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 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT02065752
Other Study ID Numbers	CR103254
Has Data Monitoring Committee	Yes
Information Provided By	Janssen Research & Development, LLC
Study Sponsor	Janssen Research & Development, LLC
Collaborators	Not Provided
Investigators	Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Verification Date	April 2014

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