bioequivalence study of Clozapine 25 mg Immediate Release Caplet manufactured by PT Lapi Laboratories in comparison with Clozapine 25 mg Immediate Release Tablet, Clozaril® manufactured by Novartis Saglik, Istanbul, Turkey; imported by Meda Pharma (Thailand) Co., Ltd Bangkok for Thailand

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-2LMZ27B
Tanggal Input Registry : 23-10-2023

29-08-2022
AUC0-t, Cmax, AUCo-inf
Tmax, t1/2
 
bioequivalence study of Clozapine 25 mg Immediate Release Caplet manufactured by PT Lapi Laboratories in comparison with Clozapine 25 mg Immediate Release Tablet, Clozaril® manufactured by Novartis Saglik, Istanbul, Turkey; imported by Meda Pharma (Thailand) Co., Ltd Bangkok for Thailand
bioequivalence study of Clozapine 25 mg Immediate Release Caplet manufactured by PT Lapi Laboratories in comparison with Clozapine 25 mg Immediate Release Tablet, Clozaril® manufactured by Novartis Saglik, Istanbul, Turkey; imported by Meda Pharma (Thailand) Co., Ltd Bangkok for Thailand
Interventional
Clozapine 25 mg Immediate Release Caplet Manufactured by PT Lapi Laboratories
22
 

Inclusion Criteria:

a. Willing to participate and agree to sign the informed consent and communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm. (ii). Respiratory rate : 12 – 20 x/minutes. (iii). Systolic blood pressure: 100 - 129 mmHg. (iv). Diastolic blood pressure: 60 - 84 mmHg. f. Have 12-lead ECG without significant abnormalities. g. Negative results of rapid test antigen Covid-19 in the screening process.

Exclusion Criteria:

a. Participate in another study within 3 (three) months prior to the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days prior to the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. g. Known hypersensitivity or contraindication to the study drug. h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. History of Granulocytopenia or myeloproliferative disorders, epilepsy, and multiple syncopal episodes o. Positive result of HBsAg, HCV, and/or HIV test.
 
KET-626/UN2.F1/ETIK/PPM.00.02/2022; S-496/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
081/BE/NOV-2021
Oktaviani Utami Dewi, S.Si - Ass. Manager QA