Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Canagliflozin, Metformin, Type 2 diabetes mellitus
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.
Interventions
Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).
Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
DRUGCANA/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.
DRUGCANA/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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of canagliflozin following the single dose of drug administration | Predose, (before tablet intake) up to 72 hours afterdose | 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 | Predose, up to 36 hours afterdose | Plasma concentrations of metformin are used to evaluate how long it stays in the body. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with adverse events as a measure of safety and tolerability | Screening, up to Day 10 of the follow-up period |
Countries
United States
Outcome results
None listed