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M0001 Effects on Oral Contraceptive Plasma Levels

NCT01036893 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-05-17

No results posted yet for this study

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

DRUG

prucalopride

prucalopride 2 mg oral dosing o.d. for 6 days

Sponsors & Collaborators

  • FOCUS GmbH

    collaborator UNKNOWN

  • Movetis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-02-28
Completion
2010-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01036893 on ClinicalTrials.gov