Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/7/2015 |
| Start Date: | August 2014 |
| End Date: | October 2014 |
| Contact: | This study is not yet recruiting patients. Please check back for future recruiting sites, or email |
| Email: | JNJ.CT@sylogent.com |
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release (IR) 1 x (50 mg/500 mg) With Respect to the Metformin IR Tablet (Locally Sourced From Canada [Glucophage, 1 x 500 mg]) Coadministered With Canagliflozin (1 x 50 mg) in Healthy Fed and Fasted Subjects
The purpose of this study to evaluate the bioequivalence (is the amount same in both the
pills) of metformin component of the canagliflozin and metformin immediate release (IR)
fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered
with canagliflozin tablet in healthy fed and fasted participants.
pills) of metformin component of the canagliflozin and metformin immediate release (IR)
fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered
with canagliflozin tablet in healthy fed and fasted participants.
This is a randomized (study medication assigned to participants by chance), open-label
(identity of study drug will be known to volunteer and study staff), single-center,
single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study
group to another in a clinical trial, like the flip of a coin) study in healthy adult
participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22
to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3
days each [Day -1 to Day 2], each separated by a washout period of 7 days) and Follow-up
Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All
eligible participants will be randomly assigned to 1 of 4 treatment sequences and will
receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will
be collected at pre-dose and post-dose of study treatment, for understanding the
pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how
it is removed from the body over time). Participants' safety will be monitored throughout
the study.
(identity of study drug will be known to volunteer and study staff), single-center,
single-dose, 4-treatment, 4-way crossover (method used to switch participants from one study
group to another in a clinical trial, like the flip of a coin) study in healthy adult
participants. The study will have 3 phases: Screening Phase (approximately 3 weeks, Day -22
to Day -2), Open-Label Treatment Phase (consisting of 4 single-dose treatment periods of 3
days each [Day -1 to Day 2], each separated by a washout period of 7 days) and Follow-up
Phase (5 to 7 days after last study-related procedure on Day 2 of treatment period 4). All
eligible participants will be randomly assigned to 1 of 4 treatment sequences and will
receive 2 treatments under fasting and 2 treatments under fed conditions. Blood samples will
be collected at pre-dose and post-dose of study treatment, for understanding the
pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how
it is removed from the body over time). Participants' safety will be monitored throughout
the study.
Inclusion Criteria:
- Body mass index (BMI) between 18.5 and 30 kilogram per square meter (kg/m^2) (inclusive)
and a body weight of not less than 50 kg
Exclusion Criteria:
- History of or current medical illness, abnormal values for hematology or clinical
chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead
electrocardiogram (ECG) deemed to be clinically significant by the Investigator
We found this trial at
1
site
Click here to add this to my saved trials
