Phase 1
N=16
Drug-drug Interaction of BI 201335 and Microgynon
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01570244 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: AUCt,ss of Ethinylestradiol — 1010; 1450 pg*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- levonorgestrel (Drug); Ethinylestradiol (Drug); BI 201335 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUCt,ss of Ethinylestradiol |
1010; 1450 | — |
| PRIMARY Cmax,ss of Ethinylestradiol |
108; 127 | — |
| PRIMARY C24,ss of Ethinylestradiol |
19.1; 33.2 | — |
| PRIMARY AUCτ,ss of Levonorgestrel |
83.3; 120 | — |
| PRIMARY Cmax,ss of Levonorgestrel |
7.57; 8.95 | — |
| PRIMARY C24,ss of Levonorgestrel |
2.43; 3.85 | — |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. |
0; 0 | — |
| SECONDARY Number of Participants With Drug Related Adverse Events |
2; 15 | — |
Summary
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel
Eligibility Criteria
Inclusion criteria
- Healthy female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01570244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.