M0001 Effects on Oral Contraceptive Plasma Levels

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).

Timeline

Start

2009-12

Primary completion

2010-02

Completion

2010-05

Publications

• Van de Velde V, Vandeplassche L, Hoppenbrouwers M, Boterman M, Ausma J. Effect of prucalopride on the pharmacokinetics of oral contraceptives in healthy women. Drugs R D. 2013 Mar;13(1):43-51. doi: 10.1007/s40268-013-0008-6.

Drugs

Indications

No indication recorded.