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Drug-drug Interaction of BI 201335 and Microgynon

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: levonorgestrel (Drug); Ethinylestradiol (Drug); levonorgestrel (Drug); BI 201335 (Drug); Ethinylestradiol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

Summary

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

Clinical Details

Official title: An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of 240 mg BI 201335 QD on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AUCt,ss of Ethinylestradiol

Cmax,ss of Ethinylestradiol

C24,ss of Ethinylestradiol

AUCĪ„,ss of Levonorgestrel

Cmax,ss of Levonorgestrel

C24,ss of Levonorgestrel

Secondary outcome:

Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.

Number of Participants With Drug Related Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion criteria: 1. Healthy female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Locations and Contacts

1220.56.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information

Starting date: April 2012
Last updated: July 3, 2015

Page last updated: August 23, 2015

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