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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Cmax,ss of Ethinylestradiol
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Test
multiple doses of Microgynon + BI 201335
Intervention: BI 201335 (Drug)
Reference
multiple doses of Microgynon
Intervention: levonorgestrel (Drug)
Reference
multiple doses of Microgynon
Intervention: Ethinylestradiol (Drug)
Test
multiple doses of Microgynon + BI 201335
Intervention: levonorgestrel (Drug)
Test
multiple doses of Microgynon + BI 201335
Intervention: Ethinylestradiol (Drug)
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)