An open-label, randomized crossover pilot study to evaluate the pharmacokinetics, bioavailability, and bioequivalence following administration of Oxybate formulations in healthy subjects.
Completed
- Conditions
- narcolepsysleeping disorder10040998
- Registration Number
- NL-OMON43111
- Lead Sponsor
- Jazz Pharmaceuticals, Inc.
- 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 of age, inclusive
BMI 20 - 30 kg/m2, inclusive
minimum bodyweight 60 kg
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 relative bioavailability and bioequivalence of the four KEY-507<br /><br>oral solutions compared with Xyrem under fasting conditions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of the four KEY-507 oral solutions and<br /><br>Xyrem under fasting conditions<br /><br>To assess the palatability of the taste of the four KEY-507 oral solutions and<br /><br>Xyrem under fasting conditions</p><br>