M0001 Effects on Oral Contraceptive Plasma Levels
This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.
The objectives of this phase I trial are to investigate in healthy female subjects:
- the effect of prucalopride on the absorption of ethinylestradiol and norethisterone acetate, the active constituents of several oral contraceptives, after the first dose of prucalopride.
- the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state), on the pharmacokinetics of ethinylestradiol and norethisterone acetate.
This trial will be conducted in healthy females of child bearing potential, i.e. females aged between 18 and 45 years (pre-menopausal).
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects|
- plasma levels oral contraceptives [ Time Frame: first days ] [ Designated as safety issue: No ]
- Plasma levels oral contraceptives after steady state [ Time Frame: 5 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|No Intervention: oral contraceptives without prucalopride|
Active Comparator: oral contraceptives with prucalopride
prucalopride 2 mg oral dosing o.d. for 6 days