bioequivalence study of Bisoprolol Fumarate 5 mg film coated tablets manufactured by PT Sampharindo Perdana in comparison Bisoprolol Fumarate 5 mg film coated tablets, Concor manufactured by PT Merck Tbk, Jakarta, Indonesia; under license by Merck Healthcare KGaA, Darmstadt, Germany
Tahapan Penelitian : Complete
Sponsor:
PT Sampharindo Perdana
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-B8YM7YA
Tanggal Input Registry : 27-10-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 31-05-2023 |
| Outcome Primer | AUC0-t , Cmax |
| Outcome Skunder | AUC0-inf , Tmax, Half life |
| Descriptive Information | |
| Judul Penelitian Popular | bioequivalence study of Bisoprolol Fumarate 5 mg film coated tablets manufactured by PT Sampharindo Perdana in comparison Bisoprolol Fumarate 5 mg film coated tablets, Concor manufactured by PT Merck Tbk, Jakarta, Indonesia; under license by Merck Healthcare KGaA, Darmstadt, Germany |
| Judul Penelitian Ilmiah | bioequivalence study of Bisoprolol Fumarate 5 mg film coated tablets manufactured by PT Sampharindo Perdana in comparison Bisoprolol Fumarate 5 mg film coated tablets, Concor manufactured by PT Merck Tbk, Jakarta, Indonesia; under license by Merck Healthcare KGaA, Darmstadt, Germany |
| Jenis Penelitian | Interventional |
| Intervensi | Bisoprolol Fumarate 5 mg film coated tablets manufactured by PT Sampharindo Perdana |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: a. Willing to participate and agree to sign 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. (v). Body temperature < 37.5°C. f. Have 12-lead ECG without significant abnormalities. g. Negative results of rapid test antigen Covid-19 at 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. Positive result of HBsAg, HCV, and/or HIV test. |
| Administrative Information | |
| Nomor Persetujuan Etik | KEt-86/UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | 074/BE/MEI-2022 |
| Contact Person | Oktaviani Utami Dewi, S.Si - Ass. Manager QA |