Determine the effects of c-administration of AZD7325 and an oral contraceptive in healthy female subjects
Study identifier:D1140C00018
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment on Hold
Official Title
A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Medical condition
pharmacokinetics
Phase
Phase 1
Healthy volunteers
Yes
Study drug
monophasic oral contraceptive, AZD7325
Sex
Female
Actual Enrollment
56
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 May 2009
Estimated Primary Completion Date: 01 Sept 2009
Estimated Study Completion Date: 01 Sept 2009
Study design
Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Other
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 monophasic oral contraceptive | Drug: monophasic oral contraceptive mg, oral dose Other Name: ORTHO-CYCLEN |
| Experimental: 2 AZD7325 | Drug: AZD7325 mg, oral dose |
Contacts
Investigators
Principal Investigator
Eleanor Lisbon
Quintiles Phase I Services
