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Bioequivalence Study of Pimavanserin 34 mg Capsule

NCT06450184 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-06-10

No results posted yet for this study

Summary

An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Pimavanserin 34 mg Capsule of Humanis Sağlık A.Ş., Turkey and NUPLAZID® (Pimavanserin) capsules of Acadia Pharmaceuticals Inc. San Diego, CA 92130 USA in normal, healthy, adult, human subjects under fasting condition.

Conditions

  • Parkinson Disease Psychosis

Interventions

DRUG

Pimavanserin 34 mg

1 capsule of Pimavanserin Capsule 34mg

DRUG

NUPLAZID 34 MG Oral Capsule

1 capsule of Pimavanserin Capsule 34mg

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2024-01-17
Completion
2024-03-09

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06450184 on ClinicalTrials.gov