Bioequivalence Study of 2 mg Estazolam (Alena®) Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Esilgan® 2 mg Tablets Manufactured by PT. Takeda Indonesia, Licensed by Takeda Pharmaceutical Company Limited, Japan

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-4CMKDZ10
Tanggal Input Registry : 06-05-2025

03-10-2025
AUC0-t , AUC0-inf , Cmax
tmax, t1/2
 
Bioequivalence Study of 2 mg Estazolam (Alena®) Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Esilgan® 2 mg Tablets Manufactured by PT. Takeda Indonesia, Licensed by Takeda Pharmaceutical Company Limited, Japan
Bioequivalence Study of 2 mg Estazolam (Alena®) Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Esilgan® 2 mg Tablets Manufactured by PT. Takeda Indonesia, Licensed by Takeda Pharmaceutical Company Limited, Japan
Interventional
Alena® 2 mg Tablet, manufactured by PT Novell Pharmaceutical Laboratories
12
 

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 ≤129 mmHg and ≥100 mmHg, diastolic blood pressure ≤84 mmHg and ≥60 mmHg) and heart rate (60-90 bpm).* 5. Accepted normal values of body temperature (35.0-37.5°C) and respiration rate (12-20 breaths/minute). 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 was 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, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 13. Negative result for pregnancy test (would be done for female subjects at screening, before period I and before period II of the study). 14. Would practice sexual abstinence or use non-hormonal contraception during the study until 1 (one) week after drug administration in period II. 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 or condition of myasthenia gravis.(1) 5. Had history or condition of severe respiratory failure.(1) 6. Had history or condition sleep apnea syndrome.(1) 7. Had history or condition of depression. 8. Hypersensitivity to estazolam, benzodiazepines or similar medication.(1,2) 9. History of alcohol, drug abuse within 12 months prior to screening for this study. 10. Received any other medications within fourteen days prior to the start of the study. 11. Participated in any clinical study within 3 months after the date of completion.
 
KET-377/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com