⮚ Bioequivalence Study of Hepamed® (Tenofovir Disoproxil Fumarate 300 mg) Film Coated Caplets Produced by PT. Dipa Pharmalab Intersains in Comparison with Viread® (Tenofovir Disoproxil Fumarate 300 mg) Tablets Manufactured for Gilead Sciences Pty Ltd, Australia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-2Z1HRYR6
Tanggal Input Registry : 08-09-2025

20-02-2025
Cmax, AUC0-t, AUC0-∞
Tmax, t ½
 
⮚ Bioequivalence Study of Hepamed® (Tenofovir Disoproxil Fumarate 300 mg) Film Coated Caplets Produced by PT. Dipa Pharmalab Intersains in Comparison with Viread® (Tenofovir Disoproxil Fumarate 300 mg) Tablets Manufactured for Gilead Sciences Pty Ltd, Australia.
⮚ Bioequivalence Study of Hepamed® (Tenofovir Disoproxil Fumarate 300 mg) Film Coated Caplets Produced by PT. Dipa Pharmalab Intersains in Comparison with Viread® (Tenofovir Disoproxil Fumarate 300 mg) Tablets Manufactured for Gilead Sciences Pty Ltd, Australia.
Interventional
Hepamed® 300 mg film coated caplet manufactured by PT Dipa Pharmalab Intersains
20
 

Inclusion Criteria:

Subjects must satisfied the following criteria to be enrolled in the study: 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 and diastolic blood pressure 61-84 mmHg) and heart rate (60-90 bpm). 5. Acceptable medical history and physical examination. 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 8. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria).* 9. Normal cardiovascular function was proven by electrocardiogram (ECG) result. 10. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. 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). 12. 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 bone abnormalities or bone fractures.(1,3) 5. Hypersensitivity to tenofovir disoproxil fumarate 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 prior the study. 9. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-1554/UN2.F1/ETIK/PPM.00.02/2024 S-888/UN2.F1/ETIK/PPM.00.02/2024 for research protocol amendments
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PPUK/PPUB number
Not Specified
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