Bioequivalence study of 300 mg Irbesartan film-coated tablet manufactured by PT Bernofarm in comparison with 300 mg Aprovel® film-coated tablet manufactured by Sanofi Winthrop Industrie, France ; under license by Sanofi Clir SNC, France; imported by PT Aventis Pharma, Jakarta, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
CRO: PT Biometrik Riset Indonesia; Regulatory: BPOM; IRB : Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia - RSUPN Dr. Cipto Mangunkusomo
No Registry
INA-AF8LWCX
Tanggal Input Registry : 20-06-2023

07-06-2021
AUC0-t, Cmax, AUC0-inf
 
Bioequivalence study of 300 mg Irbesartan film-coated tablet manufactured by PT Bernofarm in comparison with 300 mg Aprovel® film-coated tablet manufactured by Sanofi Winthrop Industrie, France ; under license by Sanofi Clir SNC, France; imported by PT Aventis Pharma, Jakarta, Indonesia
Bioequivalence study of 300 mg Irbesartan film-coated tablet manufactured by PT Bernofarm in comparison with 300 mg Aprovel® film-coated tablet manufactured by Sanofi Winthrop Industrie, France ; under license by Sanofi Clir SNC, France; imported by PT Aventis Pharma, Jakarta, Indonesia
Interventional
The test drug was the market available Irbesartan 300 mg film-coated tablet manufactured by PT Bernofarm, Indonesia; batch number : RST2-20-025B; Manufacturing date : November 11th, 2020; Expired date : November 11th, 2022.
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Inclusion Criteria:

a. Willing to participate and agree to sign informed consent, and be able to 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). Systolic blood pressure: 100 - 130 mmHg. (iii). Diastolic blood pressure: 60 - 90 mmHg. (iv). Respiratory rate : 12 – 20 x/minutes f. Have 12-lead ECG without significant abnormalities. g. Negative results of Covid-19 rapid test antigen in 1st and 2nd period.

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 was performed at screening day and prior to study drug administrations on each period). c. Smoker and 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.
 
 1065/UN2.F1/ETIK/2018 for Protocol version 1.00 (27/07/2019)  S-162/UN2.F1/ETIK/PPM.00.02/2021 for Protocol version 1.01 (18/01/2021)  S-238/UN2.F1/ETIK/PPM.00.02/2021 for Protocol version 1.02 (26/02/2021)
Not applicable
PPUK/PPUB number
Oktaviani Utami Dewi, S.Si. - Ass.man QA