Open label, partially randomized, cross-over study to determine the absolute bioavailability and pharmacokinetics of BAY 1817080 using a simultaneous anticipated therapeutic oral dose along with an i.v. [13C715N]-labeled microtracer and to investigate the relative bioavailability of two formulations given under different diets at 2 dose levels in healthy volunteers.
Completed
- Conditions
- Chronische hoest.Cough
- Registration Number
- NL-OMON46143
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
healthy male volunteers
18 - 55 years of age
weight at least 45 kilograms
BMI 18 - 30 kilograms/meter2
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>determine the absolute bioavailability and pharmacokinetics (PK) of BAY 1817080<br /><br>using a simultaneous oral dose of 100 mg<br /><br>(Formulation B, fasted state) along with an i.v. [13C715N]-labeled microtracer<br /><br><br /><br>determine the relative bioavailability of Formulation B administered in fasted<br /><br>state or with a high-fat, high-calorie meal (HF, HC) versus Formulation A<br /><br>administered with a moderate-fat, moderate-calorie meal (MF, MC) at two dose<br /><br>levels (100 and 400 mg)</p><br>
- Secondary Outcome Measures
Name Time Method <p>investigate the effect of a high-fat, high-calorie meal (HF, HC) on the PK of<br /><br>BAY 1817080 after a single oral dose of Formulation B<br /><br>at two doses (100 and 400 mg) in comparison to the fasted state<br /><br><br /><br>investigate the dose proportionality in BAY 1817080 PK after a single oral dose<br /><br>of Formulation B at 25, 100 and 400 mg in fasted state<br /><br>*<br /><br>investigate the safety and tolerability of BAY 1817080</p><br>