An open label, sequential study to assess the drug-drug interaction of Divalproex Sodium extended release (ER) at steady-state on FT218 formulation administered at a single 6 g dose in healthy volunteeers
Completed
- Conditions
- CataplexyNarcolepsy10040998
- Registration Number
- NL-OMON46476
- Lead Sponsor
- Flamel Ireland Limited (Ltd) trading under the business name Avadel Ireland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
healthy male subjects
18-55 years, inclusive
BMI 18.0-28.0 kg/m2, inclusive
Weight >= 60 kg
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>To assess the pharmacokinetics (PK) of a single 6 g dose of FT218 with or<br /><br>without 1250 mg/day divalproex sodium ER at steady-state in healthy volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety of a single dose of 6 g FT218 with or without 1250 mg/day<br /><br>divalproex sodium ER at steady-state in healthy volunteers</p><br>