M0001 Effects on Oral Contraceptive Plasma Levels

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2009
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).
Epistemonikos ID: 15677dda5d35bcc4f5f8ea2a4b14f59253a81a5a
First added on: May 05, 2024