Healthy
Conditions
Keywords
Iloperidone, VHX-896, Bioequivalence
Brief summary
This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers
Interventions
oral tablet
oral tablet
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). * Have a Body Mass Index (BMI) of \> 18.0 and \< 30.0 kg/m2; (BMI = weight (kg)/ \[height (m)\]2). * 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. * Pregnant or nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioequivalence between VHX-896 tablets relative to iloperidone tablets | 96 hours | as measured by plasma concentrations |
| Assessment of Safety and Tolerability of a single dose of VHX-896 | 17 days | As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs |
Countries
United States
Outcome results
None listed