Drug-drug Interaction of BI 201335 and Microgynon

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: BI 201335; Drug: levonorgestrel; Drug: Ethinylestradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01570244

1220.56

2011-006061-17 (EudraCT Number)

Details and patient eligibility

About

This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel

Enrollment: 16 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy female subjects

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Reference

Experimental group

Description:

multiple doses of Microgynon

Treatment:

Drug: Ethinylestradiol

Drug: levonorgestrel

Drug: levonorgestrel

Drug: Ethinylestradiol

Test

Active Comparator group

Description:

multiple doses of Microgynon + BI 201335

Treatment:

Drug: Ethinylestradiol

Drug: levonorgestrel

Drug: BI 201335

Drug: levonorgestrel

Drug: Ethinylestradiol