Healthy
Conditions
Brief summary
This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.
Interventions
No additional information
DRUGTasimelteon Oral Capsule
No additional information
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female participants between 18 to 55 years (inclusive). * Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit. * Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.
Exclusion criteria
* Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations. * Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded. * Participants with history of smoking or use of tobacco products in the last 3 months. * Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation | 8 hours | as measured by plasma concentrations |
| Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon | 7 days | as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs |
Countries
United States
Outcome results
None listed