Narcolepsy sleep / wake disorder
Conditions
Interventions
During the study, the volunteer will receive 6 gram (g) of FT218 twice (once
from Batch A and once from Batch B). The order in which the volunteer will
receive both batches will be determined by cha
Sponsors
Flamel Ireland Ltd trading under the business name Avadel Ireland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - healthy male and female subjects - 20-50 yrs, inclusive - BMI: 18.0-28.0 kg / m2, inclusive
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. Donation or loss of more than 100 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the first study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma PK parameters of gamma-hydroxybutyric acid (GHB) estimated using noncompartmental analysis, as appropriate: Cmax, tmax, kel, t1/2, AUC0-8h, AUC0-t, AUC0-inf, AUC%extra, C8h. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, physical examinations, vital signs, pulse oximetry, 12-lead electrocardiogram, and clinical laboratory tests. | — |
Countries
Netherlands
Outcome results
None listed