Uji Bioekivalensi Tablet Salut Selaput Vasotam Plus® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi PT. Pharos Indonesia Dibandingkan dengan Produk Komparator Tablet Salut Selaput Exforge® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi Novartis Farmaceutica S.A. Barbera del Valles, Spanyol untuk Novartis Pharma AG, Basel, Swiss yang diimpor oleh PT. Novartis Indonesia, Jakarta, Indonesia
Tahapan Penelitian : Complete
Sponsor:
Prima Medika Laboratories
Mitra Pelaksana:
Komite Etik Penelitian Kesehatan FKUI-RSCM, BPOM RI
No Registry
INA-987Y1Z
Tanggal Input Registry : 26-09-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 15-01-2016 |
| Outcome Primer | AUC0-t and Cmax |
| Outcome Skunder | Tmax, half-life (t1/2), safety |
| Descriptive Information | |
| Judul Penelitian Popular | Uji Bioekivalensi Tablet Salut Selaput Vasotam Plus® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi PT. Pharos Indonesia Dibandingkan dengan Produk Komparator Tablet Salut Selaput Exforge® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi Novartis Farmaceutica S.A. Barbera del Valles, Spanyol untuk Novartis Pharma AG, Basel, Swiss yang diimpor oleh PT. Novartis Indonesia, Jakarta, Indonesia |
| Judul Penelitian Ilmiah | Uji Bioekivalensi Tablet Salut Selaput Vasotam Plus® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi PT. Pharos Indonesia Dibandingkan dengan Produk Komparator Tablet Salut Selaput Exforge® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi Novartis Farmaceutica S.A. Barbera del Valles, Spanyol untuk Novartis Pharma AG, Basel, Swiss yang diimpor oleh PT. Novartis Indonesia, Jakarta, Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Amlodipine-Valsartan manufactured by the Sponsor |
| Jumlah Subyek Penelitian | 14 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Healthy male/female subjects as determined by the physical examination, medical history, and clinical laboratory tests, aged 18-55 years, body mass index (BMI) between 18-25 kg/m², normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg), normal pulse rate (60-90 bpm), normal electrocardiogram (ECG), willing to sign the informed consent after informed by the Investigator, clinical laboratory results within normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test was done to female subject during screening and right before taking the test or innovator drug), known hypersensitivity to the study drug, heavy smoker (more than ten (10) cigarettes a day), subject with liver or renal dysfunction, subject with history of drug dependency, donated or lost blood (≥450 mL) (or more) of blood within three (3) months before this study’s first dosing day, positive Hepatitis B surface antigen (HBsAg), HCV, HIV test results, subject who was being treated with other study drug or participated in previous study within three (3) months of this study’s first dosing day, intake of any over the counter (OTC) or prescription drug, food/health supplement, herbal medicine within seven (7) days of this study’s first dosing day. |
| Administrative Information | |
| Nomor Persetujuan Etik | 429/PT02.FK/ETIK/2009 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Ni Made Dwi Wulandari |