(zenuw)pijn bij diabetis en bij herpes (koortslip) neuralgia neuropathic pain
Conditions
Interventions
The study will consist of 4 periods of 4 days (3 nights), during each DS-5655
or placebo at a single dose of 10 mg will be administered at 12 hour intervals
for 3 occasions (as a morning and evening
Sponsors
Daiichi Pharmaceutical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety , tolerability Pharmacokinetics of alcohol | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of DS-5655 Pharmacodynamics by means of several cognitive assessments | — |
Countries
Netherlands
Outcome results
None listed