Bioequivalence study of Nostrok 20 mg (Rivaroxaban 20 mg) film coated tablet produced by PT Pratapa Nirmala in comparison with Xarelto® 20 mg (Rivaroxaban 20 mg) film coated tablet manufactured by Bayer AG, Leverkusen, Germany, registered and imported by PT Bayer Indonesia, under fasting condition.
Tahapan Penelitian : Complete
Sponsor:
PT Pratapa Nirmala
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-9HYPZKHH
Tanggal Input Registry : 09-09-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 19-06-2025 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Nostrok 20 mg (Rivaroxaban 20 mg) film coated tablet produced by PT Pratapa Nirmala in comparison with Xarelto® 20 mg (Rivaroxaban 20 mg) film coated tablet manufactured by Bayer AG, Leverkusen, Germany, registered and imported by PT Bayer Indonesia, under fasting condition. |
| Judul Penelitian Ilmiah | Bioequivalence study of Nostrok 20 mg (Rivaroxaban 20 mg) film coated tablet produced by PT Pratapa Nirmala in comparison with Xarelto® 20 mg (Rivaroxaban 20 mg) film coated tablet manufactured by Bayer AG, Leverkusen, Germany, registered and imported by PT Bayer Indonesia, under fasting condition. |
| Jenis Penelitian | Interventional |
| Intervensi | Test Drug: Nostrok 20 mg (Rivaroxaban 20 mg) film coated tablet produced by PT Pratapa Nirmala |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Willing to sign the informed consent, Age 18 – 55 years, Body mass index between 18 – 25 kg/m2, Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 100 beats per minute (as assessed through both pulse examination and ECG test results), respiration rate 12-20 x/minutes, body temperature 36 – 37.3°C, Healthy male/female (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination).Exclusion Criteria: Contraindicated and/or has history of hypersensitivity to Rivaroxaban or related drug, With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g., chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, or cardiovascular disease, Show abnormal result or not within the acceptance range in the electrocardiography (ECG) test result, Show abnormal result in prothrombin time (PT), activated partial prothromboplastin time (aPTT) test result, and renal function (CrCl) >50 mL/min, Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the study, Participated in any clinical study within 3 months prior to the dosing day, Donated or lost 300 mL (or more) of blood within 3 months prior to the dosing day, Smoke more than 9 sticks of cigarettes a day, Have any bleeding or coagulation disorder, With the history of alcohol and drug abuse, Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV, Pregnant or lactating female (urinary pregnancy test applied to female subjects at screening and before taking the study drug). |
| Administrative Information | |
| Nomor Persetujuan Etik | No. KET-618/ UN2.F1/ETIK/PPM.00.02/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol No. 240/FORM/OMF/2025 ver 01 Report No. 182/RPT/OMF/2025 ver 00 |
| Contact Person | apt. Kireyne E Sitanggang, S.Farm |