Overview

M0001 Effects on Oral Contraceptive Plasma Levels

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 1
Details
Lead Sponsor:
Movetis
Collaborator:
FOCUS GmbH
Treatments:
Contraceptive Agents
Contraceptives, Oral
Prucalopride