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Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

NCT01597986 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-07-16

No results posted yet for this study

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

DRUG

isavuconazole

oral

DRUG

Oral Contraceptive (ethinyl estradiol / norethindrone)

contraceptive pill consisting of ethinyl estradiol and norethindrone

Sponsors & Collaborators

  • Basilea Pharmaceutica International Ltd

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

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 NCT01597986 on ClinicalTrials.gov