An open-label, randomized, crossover, phase 1 study to evaluate bioequivalence and relative bioavailability between JZP-507 commercial scale and pilot oral solutions in healthy subjects

Completed

• Conditions: narcolepsy; sleeping disorder; 10040998

• Registration Number: NL-OMON44398
• Lead Sponsor: Jazz Pharmaceuticals, inc.

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: 30

Inclusion Criteria

- healthy male or female
- between 18 and 45 years of age, inclusive
- BMI is between 20 and 30 kilograms/meter2, inclusive, with a body weight at least 60 kilograms

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Has used any other investigational drug within 30 days or five half-lives (whichever is longer) before dosing, or plans to use an investigational drug (other than the study drug) during the study. Has donated >50 mL of blood within 60 days of randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the bioequivalence and relative bioavailability of JZP-507 oral<br /><br>solution commercial scale product versus pilot product taken with 60 mL water<br /><br>under fasting conditions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of JZP-507 oral solutions in this study</p><br>