Bioequivalence study of 5 mg Donepezil Hydrochloride (Aldomer 5) Film Coated Tablets Produced by PT. Mersifarma Tirmaku Mercusana in Comparison with Aricept 5 mg Film Coated Tablets Manufactured by Eisai Co., Ltd. Japan

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
-
No Registry
INA-2EAQA8E
Tanggal Input Registry : 28-06-2024

19-09-2023
The primary objective of this study was to establish the bioequivalence of 5 mg Donepezil Hydrochloride (Aldomer®5) film coated tablets produced by PT. Mersifarma Tirmaku Mercusana in comparison with Aricept® 5 mg film coated tablets manufactured by Eisai Co., Ltd, Japan
 
Bioequivalence study of 5 mg Donepezil Hydrochloride (Aldomer 5) Film Coated Tablets Produced by PT. Mersifarma Tirmaku Mercusana in Comparison with Aricept 5 mg Film Coated Tablets Manufactured by Eisai Co., Ltd. Japan
Bioequivalence study of 5 mg Donepezil Hydrochloride (Aldomer 5) Film Coated Tablets Produced by PT. Mersifarma Tirmaku Mercusana in Comparison with Aricept 5 mg Film Coated Tablets Manufactured by Eisai Co., Ltd. Japan
Interventional
Donepezile Mersifarma
20
 

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study : 1. Give 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 proven by electrocardiogram (ECG) result. 10. Negative result for serological test 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/tetrahydrocannabiol (THC), and benzodiazepine. 12. Negative result for pregnancy test (will be done for female subjects at screening, before period I and before period II of study). 13. Negative result for rapid antigen test of COVID-19 (Coronavirus) during COVID-19 pandemic (will be done for all subjects at screening). Note : * The clinical investigator may include a subject having value outside the accepted range, if in his/her opinion, these values are not clinically significant.

Exclusion Criteria:

Subjects will be excluded if the following reasons exist : 1. Smoker. If necessary, light smoker (≤5 cigarettes/day) can be accepted. 2. Pregnant women or nursing mother. 3. Having history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Have history or conditon of cardiac conduction abnormalities. 5. Have pre-existing or family history of QTc prolongation. 6. Have increased risk for developing ulcers. 7. Hypersensitivity to Donepezil Hydrochloride, piperidine derivatives or similar medication. 8. History of alcohol, drug abuse within 12 months prior to screening for this study. 9. Received any other medications within fourteen days prior to start of the study, 10. Participated in any clinical study within 3 months after the date of completion. 11. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-444/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
apt. Erma Suryani, S.Si.,