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
Pimavanserin 34 mg
+ NUPLAZID 34 MG Oral Capsule
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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