Clinical trial NCT01508195: A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 500 mg) in Healthy Fed Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Bioequivalence
Canagliflozin (JNJ-28431754)
Metformin IR
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 the FDC tablets (canagliflozin and metformin IR).

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 (to see if blood levels of one drug are equivalent to blood levels of another drug) 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 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 a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

Eligibility 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 ECG deemed to be clinically significant by the Investigator

Primary outcomes:
measure: Canagliflozin plasma concentrations
timeFrame: Up to 72 hours in Treatment Period 1 and Treatment Period 2
measure: Metformin plasma concentrations
timeFrame: Up to 24 hours in Treatment Period 1 and Treatment Period 2
Secondary outcomes:
measure: Changes in clinical laboratory test values
timeFrame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
measure: Changes in vital signs measurements
timeFrame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
measure: Changes in electrocardiogram (ECG) parameters
timeFrame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
measure: Changes in physical examination results
timeFrame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
measure: The number of patients reporting adverse events
timeFrame: Up to approximately 51 days (includes from time of screening through study completion including the washout interval)
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC L.L.C Clinical Trial
role: STUDY_DIRECTOR
References: