Bioequivalence Study of Nospirinal® 80 mg Enteric Coated Tablet Produced by PT. Novell Pharmaceutical Laboratories in Comparison with CardioAspirin® 100 mg Enteric Coated Tablet Manufactured by Bayer Pharma AG, Germany for Bayer Consumer Care AG, Switzerland Imported by PT Bayer Indonesia

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
NA
No Registry
INA-GD7CTRF
Tanggal Input Registry : 07-09-2023

15-07-2020
The application of parametric and non-parametric statistics reveals the presence of bioequivalence Cardioaspirin® 100 mg enteric coated tablet Manufactured by Bayer Pharma AG, Germany for Bayer Consumer Care AG, Switzerland Imported by PT Bayer Indonesia and the test drug was Nospirinal® 80 mg Enteric Coated Tablet Produced by PT. Novell Pharmaceutical Laboratories Thus it can be assumed that the two formulations were therapeutically equivalent and therefore interchangeable.
 
Bioequivalence Study of Nospirinal® 80 mg Enteric Coated Tablet Produced by PT. Novell Pharmaceutical Laboratories in Comparison with CardioAspirin® 100 mg Enteric Coated Tablet Manufactured by Bayer Pharma AG, Germany for Bayer Consumer Care AG, Switzerland Imported by PT Bayer Indonesia
Bioequivalence Study of Nospirinal® 80 mg Enteric Coated Tablet Produced by PT. Novell Pharmaceutical Laboratories in Comparison with CardioAspirin® 100 mg Enteric Coated Tablet Manufactured by Bayer Pharma AG, Germany for Bayer Consumer Care AG, Switzerland Imported by PT Bayer Indonesia
Observational
24181
 

Inclusion Criteria:

1. Gave a written informed consent 2. Healthy male and female subjects, age between 18 to 55 years old 3. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2) 4. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm) 5. Acceptable medical history and physical examination 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 8. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria). * 9. Normal cardiovascular function proven by electrocardiogram (ECG) result. 10. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV) 11. Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 12. Negative result for pregnancy test (will be done for female subjects at screening, before period I and before period II of the study). 13. Negative result for rapid test diagnostic of COVID-19 (Coronavirus). 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:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Pregnant woman or nursing mother. 3. Had condition of active or severe hepatic failure, renal failure, or congestive heart failure.(5) 4. Had history of severe hepatic impairment, hypotension (blood pressure 170/110 mmHg), and recent history of stroke.(5) 5. Potentially sensitive or hypersensitive to aspirin, salicylates, NSAIDs, analgesics, antipyretics.(5) 6. Had condition of acute gastrointestinal ulcer.(5) 7. Had condition of haemorrhagic diathesis. (5) 8. Had history of asthma induced by the administration of salicylates, NSAID, or substances with a similar action.(5) 9. Had a scheduled surgical operation, including minor surgeries e.g. dental extraction.(5) 10. History of alcohol or drug abuse within 12 months prior to screening for this study. 11. Received any other medications within 14 days prior to the start of the study, especially antacids, methotrexate, anti-coagulants or thrombolytics, oral hypoglycemic, diuretics, uricosuric agents, valproic acid, ACE inhibitors, selective serotonin re-uptake inhibitors, digoxin, other NSAID, ibuprofen.(5) 12. Participated in any clinical study within 3 months after the date of completion. 13. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
634/UN2.F1/ETIK/2017
Not applicable
PPUK/PPUB number
Fransisca