Bioequivalence Study of 600 mg Efavirenz Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Stocrin® 600 mg Film Coated Tablets Manufactured by Merck Sharp & Dohme Pty Limited, Australia for Merck Sharp & Dohme Limited, New Zealand

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-186A1XE2
Tanggal Input Registry : 28-10-2024

08-07-2025
AUC0-72h AUC0-∞ Cmax tmax t1/2
tmax
 
Bioequivalence Study of 600 mg Efavirenz Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Stocrin® 600 mg Film Coated Tablets Manufactured by Merck Sharp & Dohme Pty Limited, Australia for Merck Sharp & Dohme Limited, New Zealand
Bioequivalence Study of 600 mg Efavirenz Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Stocrin® 600 mg Film Coated Tablets Manufactured by Merck Sharp & Dohme Pty Limited, Australia for Merck Sharp & Dohme Limited, New Zealand
Interventional
Efavirenz Film Coated Tablets 600 mg Produced by PT. Novell Pharmaceutical Laboratories
37
 

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 90 mmHg, diastolic blood pressure 60 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, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 12. Negative result for pregnancy test (would be 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:

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 of seizure.(1,2) 5. Had a family history of sudden death or of congenital prolongation of the QTc interval on electrodiograms, or with any other clinical condition known to prolong the QTc interval.(2) 6. Had history or condition of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.(2) 7. Had history or condition of severe disturbances of electrolyte balance (hypokalemia or hypomagnesemia).(2) 8. Had history or condition of psychiatric disorders.(1,2) 9. Hypersensitivity to efavirenz or similar medication.(1,2) 10. History of alcohol, drug abuse within 12 months prior to screening for this study. 11. Received any other medications within fourteen days prior to the start of the study. 12. Participated in any clinical study within 3 months after the date of completion. 13. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-1808/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com