A COMPARATIVE, OPEN-LABEL, RANDOMIZED, 2 PERIODS, 2 SEQUENCES CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUSPENSION (FT218) FORMULATION (SINGLE DOSE ADMINISTERED AT THE DOSE OF 6 G) VERSUS THE MARKETED REFERENCE XYREM® (AT THE DOSE OF 2*3 G) IN HEALTHY VOLUNTEERS
Completed
- Conditions
- 10040998CataplexyNarcolepsy
- Registration Number
- NL-OMON44321
- 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
- 28
Inclusion Criteria
healthy male or female (Caucasian)
age 18 - 55 years, including
(BMI) 18.0 - 28.0 kilograms/meter2
weight at least 60 kg
not 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 relative bioavailability of a single<br /><br>dose of 6 g FT218 formulation taken 2 hours post-evening meal versus 2 doses of<br /><br>3 g of Xyrem® administered 4 hours apart, first intake 2 hours post-evening<br /><br>meal in healthy volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of a single dose of 6 g FT218 formulation<br /><br>taken 2 hours post-evening meal versus 2 doses of 3 g of the reference<br /><br>treatment (Xyrem®) administered 4 hours apart, first intake 2 hours<br /><br>post-evening meal, in healthy volunteers.</p><br>