Completed

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

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What is being tested

Pimavanserin 34 mg

+ NUPLAZID 34 MG Oral Capsule

Drug
Who is being recruted

From 18 to 45 Years
+34 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 1
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorHumanis Saglık Anonim Sirketi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 11, 2024

Actual date on which the first participant was enrolled.

This study aims to compare two different versions of the same medication, Pimavanserin, which is used to treat conditions like hallucinations and delusions. One version is produced by Humanis Sağlık in Turkey, and the other is the established brand NUPLAZID® by Acadia Pharmaceuticals in the USA. The goal is to determine if these two versions of the medication are absorbed into the body in the same way. This type of research is important to ensure that generic versions of medications are just as safe and effective as their brand-name counterparts. Participants in the study are healthy adults who receive a single dose of each version of the medication in different periods, without knowing which one they are taking. This is conducted under fasting conditions, meaning participants do not eat before taking the medication. The study uses a crossover design, where each participant receives both treatments in a random order. Researchers measure how the drug is absorbed in the body to ensure both versions perform equally. Since the study is in the early phase, it primarily focuses on how the body processes the drug rather than its effects on health conditions.

Official TitleAn 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
NCT06450184
Principal SponsorHumanis Saglık Anonim Sirketi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

16 inclusion criteria required to participate
A subject fulfilling the following criteria will be included in the present study:

Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study;

Willing to be available for the entire study period and to comply protocol requirements;

Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age;

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18 exclusion criteria prevent from participating
A subject with the following criteria will be excluded from the study:

Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;

Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;

Any major illness or hospitalized within 90 days prior to the first check-in;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Pimavanserin 34 mg Capsule

Group II

Active Comparator
NUPLAZID® (Pimavanserin) capsules 34 mg per capsule

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Raptim Research Pvt. Ltd.,

Navi Mumbai, IndiaOpen Raptim Research Pvt. Ltd., in Google Maps
CompletedOne Study Center
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 | PatLynk