Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers

Vanda Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: VHX-896 and iloperidone

Drug: Iloperidone and VHX-896

Study type

Interventional

Funder types

Industry

Identifiers

NCT04969211

VP-VHX-896-1101

Details and patient eligibility

About

This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers

Enrollment

25 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.