Microdose (i.v.) and oral potential therapeutic dose administration of S 47445 to assess absolute bioavailability and pharmacokinetic parameters of S 47445 in healthy young male volunteers. An open label 1 period study.
Completed
- Conditions
- Alzheimer's Disease10009841
- Registration Number
- NL-OMON34318
- Lead Sponsor
- Institut de Recherches Internationales Servier I.R.I.S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
healthy male volunteers
Age : 18-45 yrs
BMI : 19.0-28.0 kg/m2
Exclusion Criteria
Suffering from: hepatitis B, 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 90 days from the start of the study. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>plasma and urine S 47445 concentrations, pharmacokinetic parameters.<br /><br>total radioactivity in plasma and urine </p><br>
- Secondary Outcome Measures
Name Time Method <p>adverse events, vital signs, ECG-parameters, laboratory parameters, physical<br /><br>examination</p><br>