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 range18 Years – 45 Years
SexALL
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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…
What they're measuring
1
Maximum concentration obtained (Cmax)
Timeframe: 23 hours
2
AUC from time 0 to last collection time 72 (AUC0-72)