NCT06450184

Bioequivalence Study of Pimavanserin 34 mg Capsule

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Pimavanserin 34 mg	1 capsule of Pimavanserin Capsule 34mg
DRUG	NUPLAZID 34 MG Oral Capsule	1 capsule of Pimavanserin Capsule 34mg

Timeline

• Start date: 2024-01-11
• Primary completion: 2024-01-17
• Completion: 2024-03-09
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: India