AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, TWO-TREATMENT (FED VS FASTING), TWO-PERIOD, TWO-SEQUENCE CROSSOVER STUDY TO ASSESS THE EFFECT OF FOOD ON SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUPENSION (FT218) FORMULATION ADMINISTRERED AT 6 G IN HEALTHY VOLUNTEERS
Completed
- Conditions
- cataplexy and narcolepsy10040998
- Registration Number
- NL-OMON44554
- 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
- 16
Inclusion Criteria
healthy male or female
age 18 - 55 years, inclusive
BMI 18.0 - 28.0 kilograms/meter2, inclusive
weight 60.0 kg or more.
non smoking
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) and of a single dose of 6 g FT218 taken 30<br /><br>minutes after the start of a standardized meal (fed condition) vs. 6 g FT218<br /><br>taken after a 10-hour overnight fast (fasted condition) in healthy volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety of a single dosing of 6 g FT218 in fasted and fed states<br /><br>in healthy volunteers.</p><br>