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
Overview
- Phase
- Phase 1
- Intervention
- BI 201335
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Cmax,ss of Ethinylestradiol
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Test
multiple doses of Microgynon + BI 201335
Intervention: BI 201335
Reference
multiple doses of Microgynon
Intervention: levonorgestrel
Reference
multiple doses of Microgynon
Intervention: Ethinylestradiol
Test
multiple doses of Microgynon + BI 201335
Intervention: levonorgestrel
Test
multiple doses of Microgynon + BI 201335
Intervention: Ethinylestradiol
Outcomes
Primary Outcomes
Cmax,ss of Ethinylestradiol
Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol
C24,ss of Ethinylestradiol
Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol
AUCt,ss of Ethinylestradiol
Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration
Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol
Cmax,ss of Levonorgestrel
Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel
AUCτ,ss of Levonorgestrel
Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel
C24,ss of Levonorgestrel
Time Frame: on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel
Secondary Outcomes
- Number of Participants With Drug Related Adverse Events(from drug administration up to 14 days)
- Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.(from drug administration up to 14 days)