BIOEQUIVALENCE STUDY OF VALISANBE® 2 TABLET (2 mg DIAZEPAM) MANUFACTURED BY PT SANBE FARMA IN COMPARISON WITH VALIUM® 2 mg TABLET (2 mg DIAZEPAM) MANUFACTURED BY F. HOFFMANN-LA ROCHE AG, SWITZERLAND FOR WAYLIS THERAPEUTICS LLC, USA IN HEALTHY SUBJECTS
Tahapan Penelitian : Complete
Sponsor:
PT. Sanbe Farma
Mitra Pelaksana:
SAN-CLIN-EQ Laboratory, Prodia Clinical Laboratory
No Registry
INA-9ECWDS6
Tanggal Input Registry : 31-05-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 15-02-2024 |
| Outcome Primer | S20 |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | BIOEQUIVALENCE STUDY OF VALISANBE® 2 TABLET (2 mg DIAZEPAM) MANUFACTURED BY PT SANBE FARMA IN COMPARISON WITH VALIUM® 2 mg TABLET (2 mg DIAZEPAM) MANUFACTURED BY F. HOFFMANN-LA ROCHE AG, SWITZERLAND FOR WAYLIS THERAPEUTICS LLC, USA IN HEALTHY SUBJECTS |
| Judul Penelitian Ilmiah | BIOEQUIVALENCE STUDY OF VALISANBE® 2 TABLET (2 mg DIAZEPAM) MANUFACTURED BY PT SANBE FARMA IN COMPARISON WITH VALIUM® 2 mg TABLET (2 mg DIAZEPAM) MANUFACTURED BY F. HOFFMANN-LA ROCHE AG, SWITZERLAND FOR WAYLIS THERAPEUTICS LLC, USA IN HEALTHY SUBJECTS |
| Jenis Penelitian | Interventional |
| Intervensi | |
| Jumlah Subyek Penelitian | 10031 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Voluntary agree to sign informed consent. - Male and female subjects aged between 18–50 years. - Normal body weight (Body Mass Index/BMI :18–25 kg/m2). - Have healthy conditions based on the results of physical examination, clinical/laboratory test, and medical history. - Normal blood pressure (90–129 mmHg for systolic, and 60–84 mmHg for diastolic). - Normal pulse rate (60–100 bpm). - Normal respiratory rate (12–20 times/minutes). - Normal body temperature. - Result of 12-lead ECG without significant abnormalities.Exclusion Criteria: - History of hipersensitivity to diazepam or other benzodiazepines. - History of severe respiratory insufficiency. - History of sleep apnea syndrome. - History of myasthenia gravis. - History of narrow angle glaucoma. - History of stomach surgery. - Heavy smoker (smoke >10 cigarettes/day). - Pregnant women. - Breastfeeding women. - Alcohol and/or drug abuse. - Impaired intestinal absorption and diarrhea. - Impaired liver and renal function. - Serologically positive for HBsAg, anti-HCV, and anti-HIV during health screening. - A donation or blood loss of 300 mL (or more) within 90 days prior to drug administration. - Participation in any other bioequivalence study or clinical study within the past 90 days prior to drug administration. - Consumption of any other medicines within one week prior to drug administration. - Smoking and consumption of alcohol, coffee, tea, chocolate, cola, fruit juice, or carbonated drinks within 24 hours prior to drug administration. - Positive result on the COVID-19 antigen rapid test for prospective subjects who had not received a booster vaccine and/or subjects who experienced COVID-19 symptoms. |
| Administrative Information | |
| Nomor Persetujuan Etik | 78/UN6.KEP/EC/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Metta Bodhiloka Susilo, M.Si., MM., Apt. |