Healthy
Conditions
Keywords
Healthy Volunteers, Oral bioavailability, Canagliflozin (JNJ-28431754), Metformin IR
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.
Interventions
DRUGA (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state)
Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2.
DRUGB (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)
Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Canagliflozin plasma concentrations | Up to 72 hours |
| Metformin plasma concentrations | Up to 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to approximately 22 days | The number and type of adverse events will be reported from Day 1 of treatment period 1 through 7-10 days after treatment period 2 including the 10-14 day washout period between treatment periods (total time is approximately 22 days). |
| Clinical Laboratory Tests | Up to approximately 22 days | Clinically relevant changes from baseline occurring in laboratory safety parameters |
| Vital Signs | Up to approximately 22 days | Changes from baseline in blood pressure and pulse |
Outcome results
None listed