Bioequivalence Study of 80 mg Acetylsalicylic Acid Enteric Coated Tablet, Manufactured by PT Pharos Indonesia (Ascardia®) in Comparison with the Innovator’s 100 mg Acetylsalicylic Acid Enteric Coated Tablet (Cardio Aspirin®), Manufactured by Bayer AG, Leverkusen-Germany for Bayer Consumer Care AG, Switzerland, Imported by PT Bayer Indonesia, Depok-Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Econolab
No Registry
INA-X2O2802
Tanggal Input Registry : 13-02-2024

02-01-2024
AUC0-t and Cmax
AUC0-t, Tmax, T1/2
 
Bioequivalence Study of 80 mg Acetylsalicylic Acid Enteric Coated Tablet, Manufactured by PT Pharos Indonesia (Ascardia®) in Comparison with the Innovator’s 100 mg Acetylsalicylic Acid Enteric Coated Tablet (Cardio Aspirin®), Manufactured by Bayer AG, Leverkusen-Germany for Bayer Consumer Care AG, Switzerland, Imported by PT Bayer Indonesia, Depok-Indonesia
Bioequivalence Study of 80 mg Acetylsalicylic Acid Enteric Coated Tablet, Manufactured by PT Pharos Indonesia (Ascardia®) in Comparison with the Innovator’s 100 mg Acetylsalicylic Acid Enteric Coated Tablet (Cardio Aspirin®), Manufactured by Bayer AG, Leverkusen-Germany for Bayer Consumer Care AG, Switzerland, Imported by PT Bayer Indonesia, Depok-Indonesia
Interventional
Single dose, 5 tablets of 80 mg Acetylsalicylic Acid enteric coated tablet (Ascardia®), Manufactured by PT Pharos Indonesia
34
 

Inclusion Criteria:

Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when intercourse with spouse during the study; Healthy male/female subjects as determined by the medical screening assessments, do not show any symptoms of Covid-19; Aged 18-55 years; Body mass index (BMI) is in the range of 18-25 kg/m²; Have received the complete primary SARS-CoV-2 vaccine and at least the first booster; Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg); Normal pulse rate (60-90 bpm); Normal electrocardiogram (ECG); Clinical laboratory results must be within normal range (medical judgement of responsible physician determined any laboratory finding beyond its standard value)

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test to be applied to female subjects when screening and just before taking the test or reference drug); Known hypersensitivity or contraindication to Acetylsalicylic Acid, Ibuprofen, or other NSAIDs; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within seven (7) days of this study’s first dosing day; History of any bleeding, including non-trauma-related hemorrhage, or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; Frequent indigestion, or heartburn; History of stroke, myocardial infarction, or congestive heart failure; History of asthma, other bronchospastic activity, nasal polyps, or angioedema; History of thrombocytopenia, neutropenia, kidney or liver disease, or chronic hypertension; A donation or loss of 300 mL (or more) of blood within three (3) months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within twelve (12) months prior to the study; Heavy smoker (more than 10 cigarettes a day); Had clinically significant bleeding within three (3) months prior to the study; Participation in a previous study within three (3) months of this study’s first dosing day
 
KET-1464/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
PRO-269/23/ECL
Ni Made Dwi Wulandari