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: | May 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 150 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin XR Tablet (4 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 150 mg/1,000 mg) with respect to the individual components of
canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.
components combined in one tablet) of canagliflozin and metformin extended release (XR)
tablet (dose of 2 X 150 mg/1,000 mg) with respect to the individual components of
canagliflozin (1 x 300 mg) and metformin XR tablet (4 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 are 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 containing the 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 (150 mg CANA/1,000 mg MET XR) and will be compared
with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR
(4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A:
"Reference" treatment of individual components administered concurrently; 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 the 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, an Open-Label Treatment Phase consisting of 3 single-dose Treatment
Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase
occurring 7 to 10 days after the last study-related procedure 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 are 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 containing the 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 (150 mg CANA/1,000 mg MET XR) and will be compared
with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR
(4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A:
"Reference" treatment of individual components administered concurrently; 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 the 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, an Open-Label Treatment Phase consisting of 3 single-dose Treatment
Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase
occurring 7 to 10 days after the last study-related procedure 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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