Bioequivalence Study of ALMEN® 5 mg (Donepezil Hydrochloride 5 mg) Film Coated Tablet Produced by PT Guardian Pharmatama, Registered by PT Guardian Pharmatama in Comparison with ARICEPT® EVESS 5 mg (Donepezil Hydrochloride 5 mg) Orodispersible Tablet Manufactured by Bushu Pharmaceutical Ltd, Saitama-Ken, Japan, Packaged and Released by Interthai Pharmaceutical Ltd, Bangkok, Thailand, Imported by PT Eisai Indonesia, Bogor, Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT. Guardian Pharmatama
Mitra Pelaksana:
PT. Omega Medika Farma Laboratori
No Registry
INA-7KXNHQ5
Tanggal Input Registry : 21-08-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 07-11-2023 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of ALMEN® 5 mg (Donepezil Hydrochloride 5 mg) Film Coated Tablet Produced by PT Guardian Pharmatama, Registered by PT Guardian Pharmatama in Comparison with ARICEPT® EVESS 5 mg (Donepezil Hydrochloride 5 mg) Orodispersible Tablet Manufactured by Bushu Pharmaceutical Ltd, Saitama-Ken, Japan, Packaged and Released by Interthai Pharmaceutical Ltd, Bangkok, Thailand, Imported by PT Eisai Indonesia, Bogor, Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of ALMEN® 5 mg (Donepezil Hydrochloride 5 mg) Film Coated Tablet Produced by PT Guardian Pharmatama, Registered by PT Guardian Pharmatama in Comparison with ARICEPT® EVESS 5 mg (Donepezil Hydrochloride 5 mg) Orodispersible Tablet Manufactured by Bushu Pharmaceutical Ltd, Saitama-Ken, Japan, Packaged and Released by Interthai Pharmaceutical Ltd, Bangkok, Thailand, Imported by PT Eisai Indonesia, Bogor, Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Donepezil Hydrochloride 5 mg ® manufactured by PT. Guardian Pharmatama |
| Jumlah Subyek Penelitian | 16 |
| Recruitment Information | |
| Eligibility Criteria | 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).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, orthostatic hypotension, multiple syncopal episodes, epilepsy / seizure, primary psychiatric / neurological diagnosis, narrow-angle glaucoma or cardiovascular disease; Non-Healthy male (non-healthy criteria is determined by abnormal values or if outside the normal range of value and clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination); Show abnormal result or not within the acceptance range (clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result; 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 9 sticks of cigarettes a day; Have any bleeding or coagulation disorder; With the history of alcohol and drug abuse; Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV; If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days, b. With history or present sore throat, fever temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test |
| Administrative Information | |
| Nomor Persetujuan Etik | No. KET-1346/UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol & Report No. 138/RPT/OMF/2024 |
| Contact Person | apt. Tasha Yuliandra, M.Sc. |