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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.

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. - JZP-507 PK, BA and BE study.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45490
Enrollment
60
Registered
2017-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cataplexy narcolepsy

Interventions

Treatment A: 9 milliliters JZP-507 (equivalent to 4.5 grams sodium oxybate), no food, once. Treatment B: 9 milliliters JZP-507 (equivalent to 4.5 grams sodium oxybate), with food, once. Treatment C:
JZP-507
Narcolepsy
Xyrem

Sponsors

Jazz Pharmaceuticals
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To confirm the bioequivalence of JZP-507 oral solution compared with Xyrem oral solution under fasting conditions.—

Secondary

MeasureTime frame
To assess the food effect on pharmacokinetics of JZP-507. To assess the safety and tolerability of JZP-507 oral solution and Xyrem.—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)