Bioequivalence Study of 1 mg Entecavir Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Baraclude® 1 mg Film Coated Tablets Manufactured by AstraZeneca Pharmaceuticals LP, USA for Bristol-Myers Squibb Company, USA, Packaged by AndersonBrecon Inc., USA, Imported by BMS Korea Pharmaceuticals Co., Ltd, South Korea, Distributed by GC Biopharma Corp, South Korea
Tahapan Penelitian : Complete
Sponsor:
PT. Novell Pharmaceutical Laboratories
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
Tanggal Input Registry : 31-10-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 16-05-2025 |
| Outcome Primer | AUC0-72h, Cmax, |
| Outcome Skunder | tmax |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 1 mg Entecavir Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Baraclude® 1 mg Film Coated Tablets Manufactured by AstraZeneca Pharmaceuticals LP, USA for Bristol-Myers Squibb Company, USA, Packaged by AndersonBrecon Inc., USA, Imported by BMS Korea Pharmaceuticals Co., Ltd, South Korea, Distributed by GC Biopharma Corp, South Korea |
| Judul Penelitian Ilmiah | Bioequivalence Study of 1 mg Entecavir Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Baraclude® 1 mg Film Coated Tablets Manufactured by AstraZeneca Pharmaceuticals LP, USA for Bristol-Myers Squibb Company, USA, Packaged by AndersonBrecon Inc., USA, Imported by BMS Korea Pharmaceuticals Co., Ltd, South Korea, Distributed by GC Biopharma Corp, South Korea |
| Jenis Penelitian | Interventional |
| Intervensi | Entecavir 1 mg |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Gave a written informed consent. 2. Healthy subjects, both sexes, age between 18 to 55 years old. 3. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2). 4. Accepted normal values of blood pressure (systolic blood pressure 91-129 mmHg, diastolic blood pressure 61-84 mmHg) and heart rate (60-90 bpm). 5. Accepted normal values of body temperature (36.0-37.5°C) and respiration rate (12-20 breaths/min). 6. Acceptable medical history and physical examination. 7. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 8. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 9. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria).* 10. Normal cardiovascular function proven by electrocardiogram (ECG) result. 11. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 12. Negative result for drug of abuse tests of amphetamine, metamphetamine, opioid, marijuana/tetrahydrocannabinol (THC), and benzodiazepine (were done for all subjects at screening, before period I and before period II of the study). 13. Negative result for pregnancy test (were done for female subjects at screening, before period I and before period II of the study). Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant.Exclusion Criteria: Subjects would be excluded if the following reasons existed: 1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Pregnant women or nursing mother. 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Had history or condition of lactic acidosis or severe hepatomegaly with steatosis.(1,2,3) 5. Hypersensitivity to entecavir or similar medication.(1,2,3) 6. History of alcohol, drug abuse within 12 months prior to screening for this study. 7. Received any other medications within fourteen days prior to the start of the study. 8. Participated in any clinical study within 3 months after the date of completion. 9. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-4/UN2.F1/ETIK/PPM.00.02/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |