Clinical trial NCT01459094: Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers
Official title: Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Oral bioavailability
Canagliflozin (JNJ-28431754)
Metformin IR
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
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 see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food by healthy volunteers.

Detailed description: This is an open-label (identity of study drug will be known to volunteers and study staff), single-center study to evaluate the oral bioavailability (ie, absorption and distribution within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a fed state). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days later by Treatment A.

Eligibility criteria: Inclusion Criteria: - Body mass index (BMI) between 18 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

Primary outcomes:
measure: Canagliflozin plasma concentrations
timeFrame: Up to 72 hours
measure: Metformin plasma concentrations
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Adverse events
timeFrame: Up to approximately 22 days
measure: Clinical Laboratory Tests
timeFrame: Up to approximately 22 days
measure: Vital Signs
timeFrame: Up to approximately 22 days
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC L.LC. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Murphy J, Wang SS, Stieltjes H, Wajs E, Devineni D. Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants. Int J Clin Pharmacol Ther. 2015 Mar;53(3):256-64. doi: 10.5414/CP202233.