Healthy Volunteers Clinical Trial
Official title:
The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects
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).
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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