Bioequivalence study of Aspirin 100 mg enteric coated tablet, Miniaspi manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Aspirin 100 enteric coated tablet, Cardio Aspirin made by Bayer AG, Leverkusen - Germany for Bayer Consumer Care AG, Switserland; Imported by PT Bayer Indonesia, Depok - Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT. Mersifarma TM
Mitra Pelaksana:
-
No Registry
INA-FCC1QET
Tanggal Input Registry : 14-06-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 24-02-2024 |
| Outcome Primer | Cmax, AUC |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Aspirin 100 mg enteric coated tablet, Miniaspi manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Aspirin 100 enteric coated tablet, Cardio Aspirin made by Bayer AG, Leverkusen - Germany for Bayer Consumer Care AG, Switserland; Imported by PT Bayer Indonesia, Depok - Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence study of Aspirin 100 mg enteric coated tablet, Miniaspi manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Aspirin 100 enteric coated tablet, Cardio Aspirin made by Bayer AG, Leverkusen - Germany for Bayer Consumer Care AG, Switserland; Imported by PT Bayer Indonesia, Depok - Indonesia |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: -Exclusion Criteria: - |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1300/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 | |
| Contact Person | apt. Erma Suryani, S.Si |