Study to evaluate the pharmacokinetics of oxybate formulations in healthy subjects.

Completed

• Conditions: cataplexy; narcolepsy; 10040998

• Registration Number: NL-OMON43010
• Lead Sponsor: Jazz Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Healthy male or female Caucasion volunteers
18-45 years, inclusive
BMI 20-30 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>To assess the relative bioavailability and bioequivalence of JZP-258 oral<br /><br>solution versus Xyrem taken with 60 mL water under fasting conditions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effect of food on pharmacokinetics (PK) of JZP-258 oral solution<br /><br>and Xyrem taken with 60 mL water<br /><br>To assess the safety and tolerability of JZP-258 oral solution and Xyrem<br /><br>administered under all dosing conditions in this study</p><br>