Bioequivalence Study of 5 mg Donepezil Hydrochloride FC Tablets (Donacept®) Manufactured by PT. Novell Pharmaceutical Laboratories in Comparison with Aricept® 5 mg FC Tablets Manufactured by Eisai Manufacturing Ltd., United Kingdom

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-9QG5HWYK
Tanggal Input Registry : 05-06-2025

06-02-2017
AUC0-t , Cmax
tmax
 
Bioequivalence Study of 5 mg Donepezil Hydrochloride FC Tablets (Donacept®) Manufactured by PT. Novell Pharmaceutical Laboratories in Comparison with Aricept® 5 mg FC Tablets Manufactured by Eisai Manufacturing Ltd., United Kingdom
Bioequivalence Study of 5 mg Donepezil Hydrochloride FC Tablets (Donacept®) Manufactured by PT. Novell Pharmaceutical Laboratories in Comparison with Aricept® 5 mg FC Tablets Manufactured by Eisai Manufacturing Ltd., United Kingdom
Interventional
5 mg Donepezil Hydrochloride FC Tablets (Donacept®) Manufactured by PT. Novell Pharmaceutical Laboratories
17
 

Inclusion Criteria:

1. Healthy subjects, both sexes, age between 18 to 55 years old 2. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2) 3. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm) 4. Gave a written informed consent 5. Acceptable medical history and physical examination 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR). 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, fasting glucose, total cholesterol, 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. Acceptable electrocardiogram (ECG) result. Initial ECG would be required from subjects who had never participated in BA/BE study at Clinisindo. ECG would be required every six months from subjects who had previously participated in a BA/BE study at Clinisindo. 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).

Exclusion Criteria:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) was accepted. 2. Pregnant woman or nursing mother. 3. Had history of hepatic, gastrointestinal or renal disease. 4. Had an allergy to any medicines containing donepezil hydrochloride and piperidine derivatives 5. Had stomach problems, particularly gastric or duodenal ulcer.(9) 6. Had history of seizure.(9) 7. Had asthma or obstructive lung disease.(9) 8. Loss of memory or other mental capacity due to stroke or blood vessel problems.(9) 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. 12. Donation or loss more than 450 ml of blood within 3 months prior to the screening of the study.
 
176/UN2.F1/ETIK/2015
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com