An open-label, randomized crossover study to evaluate the pharmacokinetics, bioavailability, bioequivalence, and food effect following administration of Oxybate Formulations in healthy subjects.

An open-label, randomized crossover study to evaluate the pharmacokinetics, bioavailability, bioequivalence, and food effect following administration of Oxybate Formulations in healthy subjects. - JZP-258 Oxybate BA and FE study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41817

Enrollment

Registered

2014-07-14

Start date

2014-08-18

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

narcolepsy sleeping disorder

Interventions

The study consists of 4 treatments in which either JZP-258 or Xyrem will be administered with or without food. The order in which the volunteers will receive the treatments will be determined by cha

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers 18 - 45 years, inclusive BMI 18-30 kg/m2, inclusive non smoking

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

Measure	Time frame
Primary Objectives: To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions. To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food effect).	—

Secondary

Measure	Time frame
Secondary Objective: To assess the safety and tolerability of JZP-258 and Xyrem under fasting and fed conditions.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)