Bioequivalence Study of Ondansetron 8 mg Film-Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri in comparison with Ondansetron 8 mg Tablet, Zofran® manufactured by Aspen Bad Oldesloe GmBH, Germany; registration holder by Novartis Taiwan Co., Ltd.
Tahapan Penelitian : Complete
Sponsor:
PT Promedrahardjo Industri Farmasi
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-HN3ZYKS
Tanggal Input Registry : 16-08-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 03-07-2024 |
| Outcome Primer | AUC0-t , Cmax |
| Outcome Skunder | AUC0-inf , Tmax, Half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Ondansetron 8 mg Film-Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri in comparison with Ondansetron 8 mg Tablet, Zofran® manufactured by Aspen Bad Oldesloe GmBH, Germany; registration holder by Novartis Taiwan Co., Ltd. |
| Judul Penelitian Ilmiah | Bioequivalence Study of Ondansetron 8 mg Film-Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri in comparison with Ondansetron 8 mg Tablet, Zofran® manufactured by Aspen Bad Oldesloe GmBH, Germany; registration holder by Novartis Taiwan Co., Ltd. |
| Jenis Penelitian | Interventional |
| Intervensi | Ondansetron 8 mg Film-Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri |
| Jumlah Subyek Penelitian | 24 |
| 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 a 12-lead ECG without significant abnormalities. g. Do not have symptoms of Covid-19 and a history of close contact with Covid-19 patients h. Have received the primary SARS-CoV-2 vaccine complete and at least the first booster.Exclusion Criteria: a. Participate in another study within 3 (three) months before 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 before the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months before the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months before 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 creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-402/UN2.F1/ETIK/PPM.00.02/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Oktaviani Utami Dewi, S.Si - Ass. Manager QA Telp : 0853-2128-8082 e-Mail: oktaviani@biometrikriset.com |