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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065752
• Other study ID #: CR103254
• Secondary ID: 28431754DIA1041
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2014
• Last updated: June 16, 2014
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Canagliflozin, 100 mg
Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).
• Metformin XR, 500 mg
Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Percentage of participants with adverse events as a measure of safety and tolerability		Screening, up to Day 10 of the follow-up period	No