Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bioequivalence
Intervention: Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC] (Drug); Canagliflozin (Drug); Metformin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the bioequivalence 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 in healthy fed and
fasted participants.
Clinical Details
Official title: 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 (150 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 and 1 x 100 mg) in Healthy Fed and Fasted Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma Concentration of MetforminPlasma Concentration of Canagliflozin
Secondary outcome: Adverse EventsClinical Laboratory Test Vital Signs
Detailed description:
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
the 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 for evaluation of pharmacokinetics (how the drug is absorbed in the body,
distributed within the body, and how it is removed from the body over time) at pre-dose and
post-dose of study treatment. Participants' safety will be monitored throughout the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Lincoln, Nebraska, United States
Additional Information
Starting date: August 2014
Last updated: November 24, 2014
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