BIOEQUIVALENCE STUDY OF ALZIM (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH ARICEPT EVESS (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET MANUFACTURED BY BUSHU PHARMACEUTICAL LTD. SAITAMA-KEN, JAPAN, UNDER THE AUTHORITY OF EISAI CO., LTD. TOKYO, JAPAN, IMPORTED BY PT EISAI INDONESIA, BOGOR-INDONESIA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-HGL3DDG
Tanggal Input Registry : 08-09-2023

19-01-2023
AUC0→t, AUC0→∞, and Cmax
 
BIOEQUIVALENCE STUDY OF ALZIM (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH ARICEPT EVESS (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET MANUFACTURED BY BUSHU PHARMACEUTICAL LTD. SAITAMA-KEN, JAPAN, UNDER THE AUTHORITY OF EISAI CO., LTD. TOKYO, JAPAN, IMPORTED BY PT EISAI INDONESIA, BOGOR-INDONESIA
BIOEQUIVALENCE STUDY OF ALZIM (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH ARICEPT EVESS (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET MANUFACTURED BY BUSHU PHARMACEUTICAL LTD. SAITAMA-KEN, JAPAN, UNDER THE AUTHORITY OF EISAI CO., LTD. TOKYO, JAPAN, IMPORTED BY PT EISAI INDONESIA, BOGOR-INDONESIA
Interventional
The reference drug was Aricept Evess (10 mg Donepezil Hydrochloride) orodispersible tablet manufactured by Bushu Pharmaceutical Ltd. Saitama-Ken, Japan, under the authority of Eisai Co., Ltd. Tokyo, Japan, imported by PT Eisai Indonesia, Bogor-Indonesia, batch number 06A23P, manufacturing date 25 May 2020; expiration date on 24 May 2023. The test drug was Alzim (10 mg Donepezil Hydrochloride) orodispersible tablet produced by PT Pratapa Nirmala, batch number 1AH042; manufacturing date on August 2022; expiration date on August 2024.
16
 

Inclusion Criteria:

- Willing to sign the informed consent, - Age 18 – 55 years, Body mass index between 18 – 25 kg/m2, Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 90 beats per minute, Healthy male (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood glucose, and urinalysis; history of disease, and physical examination). Show normal result or within the acceptance range (not clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result.

Exclusion Criteria:

Contraindicated and/or has history of hypersensitivity to Donepezil or related drug With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, Participated in any clinical study within 3 months prior the study, Donated or lost 300 mL (or more) of blood within 3 months prior the study, Smoke more than 10 sticks of cigarettes a day, Have any bleeding or coagulation disorder, Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV, With the history of alcohol and drug abuse If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: With history of direct contact with a Covid-19 positive person within last 14 days, With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, Positive to Covid-19 antigen rapid test.
 
1329/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
apt. Noviyanto, S.Farm