Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01714193 | A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 2008 | Mar 1, 2008 | Nov 19, 2012 | - | — |
Comparison of plasma concentrations of ethinyl estradiol and levonorgestrel, before and after administration of multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between multiple doses of canagliflozin and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel.
| Arm | Type | Description |
|---|---|---|
| Canagliflozin + oral contraceptive | EXPERIMENTAL | Each volunteer will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel in combination with a single dose of canagliflozin. |
| Name | Type | Description |
|---|---|---|
| Oral contraceptive | DRUG | One tablet (0.150 mg of levonorgestrel and 0.030 mg of ethinyl estradiol) taken orally (by mouth) on Day 1 and Day 9. |
| Canagliflozin (JNJ-28431754) | DRUG | One 200 mg tablet taken orally (by mouth) on Days 4 through 9. |
Inclusion Criteria: * Volunteer must have a body mass index (weight \[kg\]/height \[m2\]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg * Volunteer must be a non-smoker (has not used tobacco or nicotine products in 6 months) Exclusion Criteria: * History of or currently...