An open-label, randomized, crossover study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of JZP-507 oral solution and Xyrem®in healthy subjects.
Withdrawn
- Conditions
- cataplexynarcolepsy10040998
- Registration Number
- NL-OMON45490
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Healthy male or female volunteers
18 -45 years, inclusive
BMI 20 -30 kg/m2, inclusive
Weight minimum 60 kilogram
non smokers
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 confirm the bioequivalence of JZP-507 oral solution compared with Xyrem oral<br /><br>solution under fasting conditions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the food effect on pharmacokinetics of JZP-507.<br /><br>To assess the safety and tolerability of JZP-507 oral solution and Xyrem.</p><br>