BIOEQUIVALENCE STUDY OF THROMBO ASPILETS (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY PT DARYA-VARIA LABORATORIA TBK IN COMPARISON WITH CARDIO ASPIRIN (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY BAYER PHARMA AG, LEVERKUSEN - GERMANY FOR BAYER CONSUMER CARE AG, SWITZERLAND, IMPORTED BY PT. BAYER INDONESIA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
-
No Registry
INA-KP6GBKK
Tanggal Input Registry : 05-10-2023

10-06-2023
Cmax, AUC0-t
 
BIOEQUIVALENCE STUDY OF THROMBO ASPILETS (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY PT DARYA-VARIA LABORATORIA TBK IN COMPARISON WITH CARDIO ASPIRIN (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY BAYER PHARMA AG, LEVERKUSEN - GERMANY FOR BAYER CONSUMER CARE AG, SWITZERLAND, IMPORTED BY PT. BAYER INDONESIA
BIOEQUIVALENCE STUDY OF THROMBO ASPILETS (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY PT DARYA-VARIA LABORATORIA TBK IN COMPARISON WITH CARDIO ASPIRIN (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY BAYER PHARMA AG, LEVERKUSEN - GERMANY FOR BAYER CONSUMER CARE AG, SWITZERLAND, IMPORTED BY PT. BAYER INDONESIA
Interventional
Acetylsalicylic Acid, Administered orally
24
 

Inclusion Criteria:

Willing to sign the informed consent, Age 18 – 55 years, Body mass index between 18 – 25 kg/m2, Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60- 80 mmHg), heart rate 60 – 90 beats per minute, Healthy male (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of clinical laboratory test include routine hematology, liver function, renal function, random blood glucose and urinalysis; history of disease, and physical examination), Show normal result or within the acceptance range (not clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result.

Exclusion Criteria:

Contraindicated and/or has history of hypersensitivity to Acetylsalicylic acid or related drug such as analgesic, anti-inflammatory and anti-rheumatic agents, or other allergenic agents, - With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic or recurrent gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, cardiovascular disease, status ashmaticus, hay fever, swelling of nasal mucosa (nasal polyp), or patients with chronic respiratory infection, Using any medication (prescription or non-prescription drug, food supplement) and herbal medicine within 14 days prior to dosing day, Participated in any clinical study within 3 months prior the study,Donated or lost 300 mL (or more) of blood within 3 months prior the study, Smoker more than 9 sticks of cigarettes a day, Have any bleeding or coagulation disorder, Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV, With the history of alcohol and drug abuse, If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied:a. With history of direct contact with a Covid-19 positive person in the subject neighborhood within last 14 days,, b. With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test.
 
S-194/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
S-194/UN2.F1/ETIK/PPM.00.02/2023
Fadilla Dhamayanti