NCT01036893

M0001 Effects on Oral Contraceptive Plasma Levels

The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Movetis · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	prucalopride	prucalopride 2 mg oral dosing o.d. for 6 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-02-01
• Completion: 2010-05-01
• First posted: 2009-12-21
• Last updated: 2011-05-17

Locations

1 site across 1 country: Germany