An open-label, randomized crossover study to evaluate the pharmacokinetics, bioavailability, bioequivalence, and food effect following administration of Oxybate Formulations in healthy subjects.
Completed
- Conditions
- narcolepsysleeping disorder10040998
- Registration Number
- NL-OMON41817
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Healthy male or female volunteers
18 - 45 years, inclusive
BMI 18-30 kg/m2, inclusive
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>Primary Objectives:<br /><br>To assess the relative bioavailability and bioequivalence of JZP-258 compared<br /><br>with Xyrem oral solution under fasting and fed conditions.<br /><br>To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed<br /><br>conditions (food effect).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objective:<br /><br>To assess the safety and tolerability of JZP-258 and Xyrem under fasting and<br /><br>fed conditions.</p><br>