Bioequivalence Study of 90 mg Ticagrelor Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories In Comparison with Brilinta® 90 mg Film Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by PT. AstraZeneca Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-6XR43T9
Tanggal Input Registry : 17-04-2024

08-12-2023
AUC0-t , AUC0-inf , Cmax
Tmax, Half life
 
Bioequivalence Study of 90 mg Ticagrelor Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories In Comparison with Brilinta® 90 mg Film Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by PT. AstraZeneca Indonesia
Bioequivalence Study of 90 mg Ticagrelor Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories In Comparison with Brilinta® 90 mg Film Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by PT. AstraZeneca Indonesia
Interventional
Ticagrelor Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories
24
 

Inclusion Criteria:

Give a written informed consent, healthy subjects, both sexes, age between 18 to 55 years old, weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2), accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm), acceptable medical history and physical examination, normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR), normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine, normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria), normal cardiovascular function proven by electrocardiogram (ECG) result, negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV), negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine, negative result for pregnancy test (will be done for female subjects at screening, before period I and before period II of the study), subject has either received COVID-19 (Coronavirus) vaccine minimum of first booster or negative result for rapid antigen test of COVID-19 at screening. Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant.

Exclusion Criteria:

Smoker. If necessary, light smoker (≤5 cigarettes/day) can be accepted, Pregnant women or nursing mother,Have history of hepatic, cardiovascular, gastrointestinal or renal disease, Have history or condition of intracranial hemorrhage or stroke, ave history or condition of active pathological bleeding such as peptic ulcer or intracranial hemorrhage, Have history or condition of severe hepatic impairment, Have history or condition of bleeding disorder, Have history of performance of percutaneous invasive procedure, Have history or condition of dyspnea Have schedule of any surgery during participation in this study, Have risk of bradyarrhythmia/bradycardic events, Hypersensitivity to ticagrelor or similar medication, History of alcohol, drug abuse within 12 months prior to screening for this stud, Received any other medications within fourteen days prior to the start of the study, Participated in any clinical study within 3 months after the date of completion, Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-90/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com