A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/5/2014 |
| Start Date: | February 2014 |
| End Date: | April 2014 |
| Email: | JNJ.CT@sylogent.com |
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
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.
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.
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.
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.
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
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