Healthy
Conditions
Keywords
Healthy Volunteers, Bioequivalence, Canagliflozin (JNJ-28431754), Metformin IR
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 period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.
Interventions
Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.
Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally 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 18.5 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Canagliflozin plasma concentrations | Up to 72 hours in Treatment Period 1 and Treatment Period 2 |
| Metformin plasma concentrations | Up to 24 hours in Treatment Period 1 and Treatment Period 2 |
Secondary
| Measure | Time frame |
|---|---|
| Changes in electrocardiogram (ECG) parameters | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
| Changes in clinical laboratory test values | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
| The number of patients reporting adverse events | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
| Changes in physical examination results | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
| Changes in vital signs measurements | Up to approximately 51 days (includes from time of screening through study completion including the washout interval) |
Countries
United States
Outcome results
None listed