Bioequivalence study of Aripiprazole 10 mg, Arinia - 10 Tablets manufactured by PT Meprofarm Pharmaceutical Industries in comparison with Aripiprazole 10 mg, Abilify® 10 Tablets manufactured by Korea Otsuka Pharmaceutical Co. Ltd., Korea. Imported By PT Otsuka Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-KDMFZ3
Tanggal Input Registry : 31-05-2023

24-05-2021
- AUC - Cmax
AUC0-inf
 
Bioequivalence study of Aripiprazole 10 mg, Arinia - 10 Tablets manufactured by PT Meprofarm Pharmaceutical Industries in comparison with Aripiprazole 10 mg, Abilify® 10 Tablets manufactured by Korea Otsuka Pharmaceutical Co. Ltd., Korea. Imported By PT Otsuka Indonesia.
Bioequivalence study of Aripiprazole 10 mg, Arinia - 10 Tablets manufactured by PT Meprofarm Pharmaceutical Industries in comparison with Aripiprazole 10 mg, Abilify® 10 Tablets manufactured by Korea Otsuka Pharmaceutical Co. Ltd., Korea. Imported By PT Otsuka Indonesia.
Interventional
The test drug was Arinia (Aripiprazole 10 mg) tablet manufactured by Meprofarm, batch number R0K141, manufacturing date October 2020, Expired date October 2022.
18
 

Inclusion Criteria:

1.Willing to participate and agree to sign informed consent, and be able to communicate well with the investigators, 2.Healthy female/male subjects as determined by the medical screening assessments, 3.Female subjects willing to use contraception during the study, 4.Aged 45 - 55 years inclusive, 5.Body mass index within the range of 18.00 - 25.00 kg/m2, 6.Vital signs, after 10 minutes resting, within the following ranges: (i).Pulse rate: 60 - 90 bpm, (ii).Systolic blood pressure: 100 - 130 mmHg, (iii).Diastolic blood pressure: 60 - 90 mmHg, 7.Have 12-lead ECG without significant abnormalities, 8.Negative results of Covid-19 rapid test antigen in 1st and 2nd period.

Exclusion Criteria:

1.Participate in another study within 3 (three) months prior to the first day of study drug administration, 2.Pregnant or lactating female (urinary pregnancy test was performed at screening day and prior to study, drug administrations on each period), 3.Smoker and smoking more than 10 (ten) cigarettes per day, 4.Intake of any prescription drug or non-prescription drug within 7 days prior the first day of drug administration of this study, 5.Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration, 6.History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration, 7.Known hypersensitivity or contraindication to the study drug, 8.Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery, 9.History of any bleeding or coagulative disorders, 10.History of personal or family of dystonic reaction to medication, 11.With history of diabetes and / or hyperlipidemia, 12.Clinically significant hematology abnormalities, 13.Clinically significant urinalysis abnormalities, 14.Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL), 15.History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN), 16.Positive result of HBsAg, HCV, and/or HIV test
 
KET-1/UN2/F1/ETIK/PPM.00.02/2021 S-165/UN2.F1/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
288/BE/SEP-2019
Ass. Manager QA (Oktaviani Utami Dewi, S.Si)