A RANDOMIZED, DOUBLE-BLIND DRUG-DRUG INTERACTION STUDY TO ASSESS THE EFFECT OF DS-5565 ON THE PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY AND TOLERABILITY OF ETHANOL, AND VICE VERSA IN HEALTHY SUBJECTS
Completed
- Conditions
- neuralgia(zenuw)pijn bij diabetis en bij herpes (koortslip)neuropathic pain
- Registration Number
- NL-OMON35545
- Lead Sponsor
- Daiichi Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Healthy male and female (negative pregnancy test)
age: 18-55 years (inclusive)
BMI: 19.0 - 30.0 (inclusive)
Moderate alcohol consumption; 7-21 units (males) or 5-14 units (females) of alcohol per week
Exclusion Criteria
Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 60 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 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>Safety , tolerability<br /><br>Pharmacokinetics of alcohol</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics of DS-5655<br /><br>Pharmacodynamics by means of several cognitive assessments</p><br>