Trials / Completed
CompletedNCT01597986
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
A Phase 1, Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- Female
- Age
- 50 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
Conditions
- Pharmacokinetics of Isavuconazole
- Pharmacokinetics of Ethinyl Estradiol and Norethindrone
- Healthy Volunteers
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | isavuconazole | oral |
| DRUG | Oral Contraceptive (ethinyl estradiol / norethindrone) | contraceptive pill consisting of ethinyl estradiol and norethindrone |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2012-05-15
- Last updated
- 2012-07-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01597986. Inclusion in this directory is not an endorsement.