Bioequivalence Study of 60 mg Pyridostigmine Bromide Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Mestinon® 60 mg Sugar Coated Tablets Manufactured by Labiana Pharmaceuticals S.L. Spain for A. Menarini Asia-Pacific Holdings Pte. Ltd., Singapore, Imported by PT Menarini Indria Laboratories, Indonesia, Packed and Released by PT Combiphar, Indonesia

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
NA
No Registry
INA-YARGR4T
Tanggal Input Registry : 21-09-2023

11-01-2023
The primary objective of this study was to establish the bioequivalence of 60 mg Pyridostigmine Bromide Film Coated Tablets produced by PT. Novell Pharmaceutical Laboratories in comparison with Mestinon® 60 mg Sugar Coated Tablets manufactured by Labiana Pharmaceuticals S.L. Spain for A. Menarini Asia-Pacific Holdings Pte. Ltd., Singapore, imported by PT Menarini Indria Laboratories, Indonesia, packed and released by PT Combiphar, Indonesia.
Tolerance assessment was not a major objective in this study. However, comparison of tolerance between the two products was a secondary objective
 
Bioequivalence Study of 60 mg Pyridostigmine Bromide Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Mestinon® 60 mg Sugar Coated Tablets Manufactured by Labiana Pharmaceuticals S.L. Spain for A. Menarini Asia-Pacific Holdings Pte. Ltd., Singapore, Imported by PT Menarini Indria Laboratories, Indonesia, Packed and Released by PT Combiphar, Indonesia
Bioequivalence Study of 60 mg Pyridostigmine Bromide Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Mestinon® 60 mg Sugar Coated Tablets Manufactured by Labiana Pharmaceuticals S.L. Spain for A. Menarini Asia-Pacific Holdings Pte. Ltd., Singapore, Imported by PT Menarini Indria Laboratories, Indonesia, Packed and Released by PT Combiphar, Indonesia
Observational
20
 

Inclusion Criteria:

1. Gave a written informed consent. 2. Healthy subjects, both sexes, 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 was 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 screening, before period I and before period II of the study). 13. Negative result for rapid antigen test of COVID-19 (Coronavirus) during COVID-19 pandemic (were done for all subjects 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:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 3. Had mechanical gastro-intestinal or urinary obstruction. 4. History of alcohol, drug abuse within 12 months prior to screening for this study. 5. Received any other medications within fourteen days prior to the start of the study. 6. Participated in any clinical study within 3 months prior the study. 7. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study. 8. Hypersensitivity to pyridostigmine and to bromides, or similar medication. 9. Pregnant and breastfeeding women.
 
KET-273/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
YULIEN RATU KANIA