BIOEQUIVALENCE STUDY OF PRAMIPEXOLE ER 0.375 MG EXTENDED-RELEASE TABLETS MANUFACTURED BY PT SOHO INDUSTRI PHARMASI IN COMPARISON WITH SIFROL® ER 0.375 MG EXTENDED-RELEASE TABLETS MANUFACTURED BY ROTTENDORF PHARMA GMBH, FEDERAL REPUBLIC OF GERMANY, IMPORTED BY PT BOEHRINGER INGELHEIM INDONESIA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-OYH2ERW
Tanggal Input Registry : 01-11-2024

06-06-2024
Cmax, AUCt, and AUCinf
Tmax, T1/2
 
BIOEQUIVALENCE STUDY OF PRAMIPEXOLE ER 0.375 MG EXTENDED-RELEASE TABLETS MANUFACTURED BY PT SOHO INDUSTRI PHARMASI IN COMPARISON WITH SIFROL® ER 0.375 MG EXTENDED-RELEASE TABLETS MANUFACTURED BY ROTTENDORF PHARMA GMBH, FEDERAL REPUBLIC OF GERMANY, IMPORTED BY PT BOEHRINGER INGELHEIM INDONESIA
BIOEQUIVALENCE STUDY OF PRAMIPEXOLE ER 0.375 MG EXTENDED-RELEASE TABLETS MANUFACTURED BY PT SOHO INDUSTRI PHARMASI IN COMPARISON WITH SIFROL® ER 0.375 MG EXTENDED-RELEASE TABLETS MANUFACTURED BY ROTTENDORF PHARMA GMBH, FEDERAL REPUBLIC OF GERMANY, IMPORTED BY PT BOEHRINGER INGELHEIM INDONESIA
Interventional
Pramipexole ER 0.375 mg
20
 

Inclusion Criteria:

Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures, Subjects healthy male and female, Subjects’ age ranges from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range: Systolic blood pressure 110 – 129 mmHg; Diastolic blood pressure 70 – 84 mmHg; Pulse/Heart rate 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Subjects had received the complete primary SARS CoV-2 vaccine, Subjects had negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine)

Exclusion Criteria:

those who were pregnant and/or nursing women (for women), those with history of contraindication or hypersensitivity to pramipexole, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction, those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestinal surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease, those with history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who had history of orthostatic hypotension, those who were disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period, those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day, those who participated in any clinical study within the past 90 days prior to the study, those who donated or losing 300 mL (or more) of blood within 3 months prior to the study, those who had smoking habit with more than 10 cigarettes a day, those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days prior to screening, those who had history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days, those who had positive result for HIV, HbsAg, and HCV tests (to be kept confidential), those who had history of drug or alcohol abuse within 12 months prior to screening for this study, those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-133/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
786/STD/PML/2023
Virrisya