Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Bekasi, Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-Q5PS1FG
Tanggal Input Registry : 14-08-2023

21-12-2022
Cmax, AUC0-t
 
Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Bekasi, Indonesia.
Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Bekasi, Indonesia.
Interventional
Ticagrelor 90 mg Film-Coated Tablets
24
 

Inclusion Criteria:

Subjects had read the subject information and signed informed consent documents, Subjects healthy male and female, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2,Subjects had a normal electrocardiogram, Subjects had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg), Subjects had the heart rate within normal range (60 – 100 bpm), Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history, or physical examination during screening, Subjects accepted to use protection (condom) before any intercourse with their spouse throughout the study until 7 days after the last drug administration.

Exclusion Criteria:

Those who were pregnant and/or nursing condition, Those with a history of contraindication or hypersensitivity to ticagrelor or other antiplatelets, or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction, Those with a history or presence of 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, Those with history or presence of any coagulation disorder or clinically significant hematology abnormalities,Those who had history or presence of pathological bleeding such as peptic ulcer or intracranial hemorrhage, Those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day, Those who had participated in any clinical study within 3 months prior to the study (< 90 days), Those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study,. Those who smoked more than 10 cigarettes a day, Those who had history of travelling to another city within the last 14 days without following health authority regulation, Those who had of direct contact with a COVID-19 positive person in the subject’s neighborhood within 3 days prior to screening, Those who had history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days,Those who was positive to SARS-CoV-2 antigen test, Those who was positive to 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 was unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-847/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
685/STD/PML/2022
Nabila Mudin S