Trials / Terminated
TerminatedNCT04131517
A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- UCB Biopharma SRL · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to investigate the effect of steady-state padsevonil on the pharmacokinetic of a single dose oral contraceptive.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Padsevonil | Study Medication: Padsevonil Dosage formulation: Oral tablets; 400 mg BID (Part 1) and 200 mg BID (Part 2) |
| DRUG | Microgynon 30® | Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg |
Timeline
- Start date
- 2019-10-23
- Primary completion
- 2020-05-22
- Completion
- 2020-05-22
- First posted
- 2019-10-18
- Last updated
- 2021-06-24
- Results posted
- 2021-06-24
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04131517. Inclusion in this directory is not an endorsement.