A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/5/2014 |
| Start Date: | March 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 50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects
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 50 mg/1000
mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR
tablet (4 x 500 mg) in healthy fed participants.
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 50 mg/1000
mg) with respect to the individual components of canagliflozin (1 x 100 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 provided to all participants but in
different sequence) study of Fixed Dose Combination (FDC) tablets of canagliflozin (CANA)
and metformin extended release (MET XR) 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/1,000 mg MET XR) and will be
compared with equal doses of the individual drugs: canagliflozin (1 x 100 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. 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 Fixed Dose Combination (FDC) tablets of canagliflozin (CANA)
and metformin extended release (MET XR) 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/1,000 mg MET XR) and will be
compared with equal doses of the individual drugs: canagliflozin (1 x 100 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. 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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