A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives
Study identifier:D9830C00015
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-018864-18
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers
Medical condition
oral contraceptives
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1981, Neovletta 21/28, Placebo AZD1981
Sex
Female
Actual Enrollment
28
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 May 2010
Primary Completion Date: 01 Oct 2010
Study Completion Date: 01 Oct 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1981 + Oral contraceptive | Drug: AZD1981 4X100 mg per oral, twice daily for 28 days Drug: Neovletta 21/28 Once daily with (21) or without (28) pause for bleeding. Other Name: Neovletta 21/28 |
| Placebo Comparator: 2 Placebo + Oral contraceptive | Drug: Neovletta 21/28 Once daily with (21) or without (28) pause for bleeding. Other Name: Neovletta 21/28 Drug: Placebo AZD1981 4X100 mg per oral, twice daily for 28 days |
Contacts
Investigators
Principal Investigator
Eva S Pettersson
AstraZeneca R&D
