Bioequivalence study of Aspirin 100 mg, Aptor enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia in comparison with Aspirin 100 mg, Cardio Aspirin ® enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. BIOMETRIK RISET INDONESIA
No Registry
INA LTKMPXL
Tanggal Input Registry : 23-02-2023

20-10-2022
Cmax (ng/mL) dan AUC0-t (ng.h/mL
AUC-Inf (ng.h/mL), Tmax, T1/2
 
Bioequivalence study of Aspirin 100 mg, Aptor enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia in comparison with Aspirin 100 mg, Cardio Aspirin ® enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia
Bioequivalence study of Aspirin 100 mg, Aptor enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia in comparison with Aspirin 100 mg, Cardio Aspirin ® enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia
Interventional
The References drug, Cardio Aspirin (Aspirin 100mg) enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia; Batch Number BXJK5T1; Manufacturing Date on December 2020; Expired Date on December 2023. The Test Drug, Aptor (Aspirin 100mg) enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia Batch Number 2C 100322, Manufacturing Date on March 2022; Expired Date on March 2024. In sampling day, subject took 1 dose of aspirin products of either formulation (Reference or Test) With 240 mL water according to randomization in each periods in sitting position.
20
 

Inclusion Criteria:

- Willing to participate and agree to sign informed consent and communicate well with the investigators. - Healthy female/male subjects as determined by the medical screening assessments. - Aged 18 - 55 years inclusive. - Body mass index within the range of 18.00 - 25.00 kg/m - Vital signs, after 10 minutes resting, within the following ranges: A. Pulse rate: 60 - 90 bpm. B. Respiratory Rate: 12 - 20 x/minutes. C. Systolic blood pressure: 100 - 129 mmHg. D. Diastolic blood pressure: 60 - 84 mmHg. E. Body temperature < 37.5°C - Have 12-lead ECG without significant abnormalities. - Negative results of rapid test antigen Covid-19 at screening process.

Exclusion Criteria:

- Participate in another study within 3 (three) months prior to the first day of study drug administration. - Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). - Smoker or smoking more than 10 (ten) cigarettes per day. - Intake of any prescription drug or non-prescription drug within 7 days prior to the first day of drug administration of this study. - Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. - History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. - Known hypersensitivity or contraindication to the study drug. - Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. - History of any bleeding or coagulative disorders. - Clinically significant hematology abnormalities. - Clinically significant urinalysis abnormalities. - Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). - History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). - Positive result of HBsAg, HCV, and/or HIV test.
 
KET-966/UN2.F1/ETIK/PPM.00.02/2021
079/BE/JUL-2021
Safitri Nur Afifah