narcolepsy sleeping disorder
Conditions
Interventions
The study consists of 2 treatments with JZP-507 which will be administered
after 10 hours of overnight fasting. The order in which the volunteer will
receive the treatments will be determined by cha
Narcolepsy
Sponsors
Jazz Pharmaceuticals, inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence and relative bioavailability of JZP-507 oral solution commercial scale product versus pilot product taken with 60 mL water under fasting conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of JZP-507 oral solutions in this study | — |
Countries
The Netherlands
Outcome results
None listed