A Phase 1 interventional study of Canagliflozin, 300 mg and Metformin XR, 500 mg in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-01.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150 mg/500mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (2 x 500 mg) in healthy fed participants.
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 a Fixed Dose Combination (FDC) tablets of canagliflozin (CANA) and metformin extended release (MET XR) in comparison with tablets of individual components. Two FDC tablets will be studied with different formulations of MET XR component (CANA component will be identical). Both FDCs will be of the same strength: 2 tablets of 150mg CANA/500mg MET XR and will be compared with the equal doses of the individual drugs: canagliflozin (1 x 300mg tablet) and metformin XR (2 x 500mg 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.
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Exclusion Criteria:
Each participant will receive a single dose of 1 tablet of canagliflozin (CANA), 300 mg, and 2 tablets of metformin extended release (MET XR), 500 mg, administered together under fed conditions.
Drug: Canagliflozin, 300 mg · Drug: Metformin XR, 500 mg
Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC (2 x \[150 mg/500 mg\]) formulation 1, under fed conditions.
Drug: CANA/MET XR FDC, Formulation 1, 150 mg/500
Each participant will receive a single dose of 2 tablets of CANA/MET XR FDC (2 x \[150 mg/500 mg\]), formulation 2, under fed conditions.
Drug: CANA/MET XR FDC, Formulation 2, 150 mg/500 mg
Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth).
Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
Also known as: GLUMETZA
Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, to be taken orally.
Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, to be taken orally.
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.
Time frame: Day 1 to Day 2 (predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours postdose); Day 3 (48 hour); and Day 4
Plasma concentration of metformin extended release following the single dose of drug administration
Plasma concentrations of metformin are used to evaluate how long it stays in the body.
Time frame: Day 1 to Day 2 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, and 30 hours postdose); and Day 3 (36 hours)
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to Day 10 of the follow-up period
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC