Bioavailability/bioequivalence study of Risperidone 1 mg Film Coated Caplets manufactured by PT. Bernofarm, Indonesia in comparison with Risperidone 1 mg, Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-F4516R0
Tanggal Input Registry : 22-06-2023

21-09-2020
AUC0-t, Cmax
 
Bioavailability/bioequivalence study of Risperidone 1 mg Film Coated Caplets manufactured by PT. Bernofarm, Indonesia in comparison with Risperidone 1 mg, Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy.
Bioavailability/bioequivalence study of Risperidone 1 mg Film Coated Caplets manufactured by PT. Bernofarm, Indonesia in comparison with Risperidone 1 mg, Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy.
Interventional
The test drug was the market available Risperidone 1 mg Film Coated Caplets manufactured by PT Bernofarm, Indonesia; batch number : RST2-19-001E; Manufacturing date : January 17th, 2019; Expired date : January, 2021. The reference drug was the market available Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy; batch number : IJL4600; Expired date : September 2021. In sampling day, Subjects took one dose of Risperidone products of either formulation (Reference or Test) after an overnight fasted. As randomization scheme with 240 mL of water in sitting position. The subjects blood samples was taken at a certain times.
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Inclusion Criteria:

a. Able to participate, agree to sign an informed consent, and communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. a. Aged 18 - 55 years inclusive. b. Body mass index within the range of 18.00 - 25.00 kg/m2. c. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm. (ii). Systolic blood pressure: < 120 mmHg. (iii). Diastolic blood pressure: < 80 mmHg. d. Have 12-lead ECG without significant abnormalities. e. Negative results of Covid-19 on stage 1 and 2 on IgM, IgG CoV-2 SARS testing and thorax X-ray testing

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 at screening day and prior to study drug administrations on each period). c. Smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days prior 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. Positive result of HBsAg, HCV, and/or HIV test.
 
S-795/UN2. F1/ETIK/PPM.00.02.2020 (versi 1.02); S-17/UN2.F1/ETIK/PPM.00.02/2020 (versi 1.01); KET-1224/UN2.F1/ETIK/PPM.00.02/2019 (versi 1.00)
Not applicable
PPUK/PPUB number
Oktaviani Utami Dewi, S.Si. - Ass.man QA