Bioequivalence Study of Pimavanserin 34 mg Capsule

NCT06450184 | Completed Phase 1

• 1 other identifier: PR/BE/23/296
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Maximum concentration obtained (Cmax)

  two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data Cmax

  23 hours

• AUC from time 0 to last collection time 72 (AUC0-72)

  two-sided 90% CI for the test to reference ratio of the population means is within 80.00% to 125.00% for each of the Ln-transformed data AUC0-72

  23 hours

Secondary Outcomes (1)

• Time of the maximum measured plasma concentration (Tmax)

  23 hours

Study Arms (2)

Pimavanserin Capsule

EXPERIMENTAL

Pimavanserin 34 mg Capsule

Drug: Pimavanserin 34 mg

NUPLAZID® Capsules

ACTIVE COMPARATOR

NUPLAZID® (Pimavanserin) capsules 34 mg per capsule

Drug: NUPLAZID 34 MG Oral Capsule

Interventions

Pimavanserin 34 mg DRUG

1 capsule of Pimavanserin Capsule 34mg

Pimavanserin Capsule

NUPLAZID 34 MG Oral Capsule DRUG

1 capsule of Pimavanserin Capsule 34mg

NUPLAZID® Capsules

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Body mass index in the range of 18.50 - 30.00 kg/m2 (both inclusive);
• Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period;
• Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis;
• Normal or clinically non-significant 12-lead ECG recording;
• Non-smokers;
• Willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period;
• Non-alcoholic;
• Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period;
• Willing to abstain from grapefruit or its juice at least 72.00 hours prior to checkin until last sample collection in each study period;
• For female subjects:
• Negative urine pregnancy test during screening and negative serum β-hCG test at the time of check-in of each study period;

You may not qualify if:

• 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;
• Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study;
• Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study;
• Use of any prescribed medication (including known to prolong QT interval, herbal medicines and vitamin supplements) or OTC products within 30 days prior to first check-in and throughout the study;
• Presence of dementia related psychosis;
• History or presence of significant gastric and/or duodenal ulceration;
• Difficulty in swallowing tablets or capsules;
• Use of any recreational drug or history of drug addiction;
• Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first check-in;
• Positive urine alcohol and urine drug of abuse tests during check-in of each study period;
• Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;
• Lactating or nursing female subjects;

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

Raptim Research Pvt. Ltd.,

Navi Mumbai, India

Location

MeSH Terms

Interventions

pimavanserin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: January 11, 2024
• Primary Completion: January 17, 2024
• Study Completion: March 9, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)