Drug-drug Interaction of BI 201335 and Microgynon

Boehringer Ingelheim16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

levonorgestrelDRUG

multiple doses

EthinylestradiolDRUG

multiple doses

levonorgestrelDRUG

multiple doses

BI 201335

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

1220.56.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

AUCt,ss of Ethinylestradiol

Area under the curve over the dosing interval t under steady state conditions 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

Cmax,ss of Ethinylestradiol

maximum measured concentration over the uniform dosing interval under steady state conditions 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

C24,ss of Ethinylestradiol

measured concentration of the analyte at the end of dosing interval under steady state conditions 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

AUCτ,ss of Levonorgestrel

Area under the curve over the dosing interval τ under steady state conditions 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

Cmax,ss of Levonorgestrel

maximum measured concentration over the uniform dosing interval under steady state conditions 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

C24,ss of Levonorgestrel

measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

Time frame: from drug administration up to 14 days

Number of Participants With Drug Related Adverse Events

number of participants with investigator-defined drug related adverse events

Time frame: from drug administration up to 14 days