Bioequivalence Study of Rivatrop® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by PT Tropica Mas Pharmaceuticals in Comparison with Xarelto® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by Bayer AG, Germany Imported by PT Bayer Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Tropica Mas Pharmaceuticals
Mitra Pelaksana:
No Registry
INA-NF6NED0
Tanggal Input Registry : 17-04-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 09-12-2023 |
| Outcome Primer | AUC0-t dan Cmax |
| Outcome Skunder | AUC0-inf, Tmax, Half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Rivatrop® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by PT Tropica Mas Pharmaceuticals in Comparison with Xarelto® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by Bayer AG, Germany Imported by PT Bayer Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of Rivatrop® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by PT Tropica Mas Pharmaceuticals in Comparison with Xarelto® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by Bayer AG, Germany Imported by PT Bayer Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Rivatrop® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by PT Tropica Mas Pharmaceuticals |
| Jumlah Subyek Penelitian | 28 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Willing to sign informed consent, healthy subjects as determined by the medical laboratory test (routine hematology, liver function, renal function, blood glucose, urinalysis), medical history, and physical examination (result that are not in normal range but clinically insignificant by medical doctor justification could be considered healthy), male or female, age between 18-55 years, normal body weight (Body Mass Index= 18-25 kg/m2), blood pressure: systolic 100-129 mmHg, diastolic 60-84 mmHg, pulse rate 60-90 bpm, willing to use non hormonal contraception during study, have received the primary SARS-CoV-2 vaccine complete and at least the first booster or SARS-CoV-2 antigen rapidtest give a nonreactive result.Exclusion Criteria: History of allergy or hypersensitivity or contraindication to rivaroxaban, any major illness in the past 90 days or clinically significant ongoing chronic medical illness, history of bleeding or blood clotting disorders, prothrombin time (PT) and activated partial thromboplastin time (aPTT) out of normal range, creatinine clearance (CrCl) < 50 mL/min, history of drug or alcohol abuse, participation in any clinical trial or blood donation or significant blood loss more than 300 mL within the past 3 months prior study, positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, pregnant or lactating female (urinary pregnancy test applied to female subjects at screening and before taking the study drug at Period I and II), any medical condition (present or history) which might affect drug kinetics, smoking more than 10 (ten) cigarettes per day, history of major illness, e.g. heart failure, hepatitis, hypotension, hyperglycemia, hypertension, etc., intake of any drug or food supplements less than 7 days since the start of study, abnormal electrocardiogram (ECG), history of close contact with Covid-19 patients within 14 days prior study |
| Administrative Information | |
| Nomor Persetujuan Etik | 67/UN6.KEP/EC/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | 02/PRO-BE/FLIU/I/2023 |
| Contact Person | apt. Eva Sumiyarni, S.Si. |