Bioequivalence Study of Pimavanserin 34 mg Capsule (NCT06450184) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Pimavanserin 34 mg Capsule
India32 participantsStarted 2024-01-11
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 preg…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum concentration obtained (Cmax)
Timeframe: 23 hours
2
AUC from time 0 to last collection time 72 (AUC0-72)