Bioequivalence Study of 15 mg Aripiprazole Tablets, Manufactured by PT. Amarox Pharma Global (Aripiprazole) in Comparison with the Innovator’s Tablets (Abilify®), Manufactured by Korea Otsuka Pharmaceutical Co., Ltd., Gyeonggi-do, Korea, under Authorization of Otsuka Pharmaceutical Co., Ltd., Japan, Imported by PT. Otsuka Indonesia, Malang, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Econolab
No Registry
INA-FTKG6HY
Tanggal Input Registry : 09-02-2024

18-09-2021
AUC0-t and Cmax
AUC0-∞, Tmax, T1/2
 
Bioequivalence Study of 15 mg Aripiprazole Tablets, Manufactured by PT. Amarox Pharma Global (Aripiprazole) in Comparison with the Innovator’s Tablets (Abilify®), Manufactured by Korea Otsuka Pharmaceutical Co., Ltd., Gyeonggi-do, Korea, under Authorization of Otsuka Pharmaceutical Co., Ltd., Japan, Imported by PT. Otsuka Indonesia, Malang, Indonesia
Bioequivalence Study of 15 mg Aripiprazole Tablets, Manufactured by PT. Amarox Pharma Global (Aripiprazole) in Comparison with the Innovator’s Tablets (Abilify®), Manufactured by Korea Otsuka Pharmaceutical Co., Ltd., Gyeonggi-do, Korea, under Authorization of Otsuka Pharmaceutical Co., Ltd., Japan, Imported by PT. Otsuka Indonesia, Malang, Indonesia
Interventional
Single dose of one tablet of 15 mg (Aripiprazole), Manufactured PT Amarox Pharma Global
18
 

Inclusion Criteria:

Willing to use contraception (condoms) when intercourse with spouse during the study, able to participate, communicate well with the investigators and agree to sign an informed consent; Healthy male/female subjects as determined by the medical screening assessments; Aged 40-55 years of age; Body mass index (BMI) is in the range of 18-25 kg/m²; Systolic blood pressure:100-120 mmHg; Diastolic blood pressure: 60-80 mmHg; Pulse rate 60-90 bpm; Normal electrocardiogram (ECG); Clinical laboratory results have to be within normal range.

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test were applied to female subjects when screening and just before taking the test or innovator drug); Known hypersensitivity or contraindication to the study drug; intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day; History of any bleeding or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; A donation or loss of 300 mL (or more) of blood within 3 months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within 12 months prior to this study; Heavy Smoker (more than 10 cigarettes a day); Clinically have significant bleeding within 3 months prior to the study; Participation in a previous study within 3 months of this study’s first dosing day; Subject with historical medication of dystonia (personal or family); Subject with neuroleptic agent usage; A reactive antibody Corona virus (Covid-19) test result.
 
KET-865/UN2.F1/ETIK/PPM.00.02/2019
Not applicable
PPUK/PPUB number
PRO-245/19/ECL
Ni Made Dwi Wulandari