Bioequivalence Study Diazepam 5 mg Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Diazepam 5 mg Tablet, Valium® manufactured by Waylis Therapeutics LLC Wixom, MI 48393 under fasting condition
Tahapan Penelitian : Complete
Sponsor:
PT. Mersifarma Tirmaku Mercusana
Mitra Pelaksana:
Not Specified
No Registry
INA-2C8WC62H
Tanggal Input Registry : 11-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 10-10-2024 |
| Outcome Primer | AUC0-t, Cmax |
| Outcome Skunder | AUC0-inf , Tmax, Half life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study Diazepam 5 mg Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Diazepam 5 mg Tablet, Valium® manufactured by Waylis Therapeutics LLC Wixom, MI 48393 under fasting condition |
| Judul Penelitian Ilmiah | Bioequivalence Study Diazepam 5 mg Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Diazepam 5 mg Tablet, Valium® manufactured by Waylis Therapeutics LLC Wixom, MI 48393 under fasting condition |
| Jenis Penelitian | Interventional |
| Intervensi | Diazepam 5 mg Tablet manufactured by PT Mersifarma Tirmaku Mercusana |
| Jumlah Subyek Penelitian | 24 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Not SpecifiedExclusion Criteria: Not Specified |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-747/UN2.FI/ETIK/PPM.00.02/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | |
| Contact Person | apt. Erma Suryani, S.Si |