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CompletedNCT04969211Updated Jul 11, 2022

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

A Phase 1 interventional study of VHX-896 and iloperidone and Iloperidone and VHX-896 in Healthy, sponsored by Vanda Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by Vanda Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2021, 4 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy

Keywords

  • Iloperidone
  • VHX-896
  • Bioequivalence
03

In context

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Sequence A: VHX-896 then iloperidone

    Drug: VHX-896 and iloperidone

  • Experimental
    Sequence B: Iloperidone then VHX-896

    Drug: Iloperidone and VHX-896

Interventions

  • DrugVHX-896 and iloperidone

    oral tablet

  • DrugIloperidone and VHX-896

    oral tablet

06

What researchers measure

Primary outcomes

  1. Bioequivalence between VHX-896 tablets relative to iloperidone tablets

    as measured by plasma concentrations

    Time frame: 96 hours

  2. 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

    Time frame: 17 days

07

Study locations

1 site
  • Vanda Investigational Site
    Springfield, Missouri 65802, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04969211
Lead sponsor
Vanda Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 20, 2021
Start date
Jun 30, 2021
Primary completion
Oct 13, 2021
Completion
Oct 13, 2021
Last update
Jul 11, 2022

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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