A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets) (Drug); B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Summary
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC)
tablets of canagliflozin and metformin immediate release (IR) in comparison with the
individual components of canagliflozin and metformin IR.
Clinical Details
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagl
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Canagliflozin plasma concentrationsMetformin plasma concentrations
Secondary outcome: Adverse eventsClinical laboratory tests Vital signs
Detailed description:
This is an open-label (identity of study drug will be known to volunteer and study staff),
single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when
administered orally (by mouth) as individual components (ie, separate tablets of
canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose
combination (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet)
(Treatment B). Healthy volunteers participating in the study will be randomly (by chance)
assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment
A with a period of approximately 15 days between treatments.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: - Body mass index (BMI) between 18. 5 and 30 kg/m² (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
Tempe, Arizona, United States
Additional Information
Starting date: September 2011
Last updated: August 28, 2012
|