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contraceptive · 1 trial · 1 indication
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...
The drug is an oral contraceptive studied in a Phase 1 trial by Johnson & Johnson (JNJ). It is a small molecule being evaluated for its interaction with canagliflozin (JNJ-28431754) in healthy volunteers. The trial, NCT01714193, has been completed with 30 female participants.
The contraceptive drug is an oral contraceptive intended for use in healthy female volunteers. It was studied in a completed Phase 1 clinical trial to assess the effects of canagliflozin on its pharmacokinetics and safety. The trial enrolled 30 women aged 18 years and older.
Johnson & Johnson (ticker: JNJ) is the developer of the contraceptive drug. The company conducted a Phase 1 clinical trial, NCT01714193, to evaluate the drug's interaction with canagliflozin in healthy volunteers. The trial has been completed.
The contraceptive drug is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT01714193, which assessed its pharmacokinetics and safety when combined with canagliflozin in healthy female volunteers. The drug is investigational and not yet approved.
The contraceptive drug has one completed clinical trial, NCT01714193, titled 'A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers.' This Phase 1 study enrolled 30 healthy female participants and was not randomized or double-blinded.