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

Healthy Clinical Trial

Official title:

An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969211
• Other study ID #: VP-VHX-896-1101
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2021
• Est. completion date: October 13, 2021

Study information

• Verified date: July 2022
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• VHX-896 and iloperidone
oral tablet
• Iloperidone and VHX-896
oral tablet

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence between VHX-896 tablets relative to iloperidone tablets	as measured by plasma concentrations	96 hours
Primary	Assessment of Safety and Tolerability of a single dose of VHX-896	As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs	17 days