Bioequivalence study of Sharox 500 (500 mg Cefuroxime) film coated caplet produced by PT. Pratapa Nirmala in comparison with Zinnat (500 mg Cefuroxime) film coated tablet produced by Glaxo Wellcome Operations, Barnard Castle, UK, imported by PT. Glaxo Wellcome Indonesia

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Omega Medika Farma Laboratori
No Registry
INA-T79N
Tanggal Input Registry : 01-12-2022

30-10-2021
AUC0-t and Cmax
AUC0-∞, T1/2, Tmax
 
Bioequivalence study of Sharox 500 (500 mg Cefuroxime) film coated caplet produced by PT. Pratapa Nirmala in comparison with Zinnat (500 mg Cefuroxime) film coated tablet produced by Glaxo Wellcome Operations, Barnard Castle, UK, imported by PT. Glaxo Wellcome Indonesia
Bioequivalence study of Sharox 500 (500 mg Cefuroxime) film coated caplet produced by PT. Pratapa Nirmala in comparison with Zinnat (500 mg Cefuroxime) film coated tablet produced by Glaxo Wellcome Operations, Barnard Castle, UK, imported by PT. Glaxo Wellcome Indonesia
Eksperimental
The reference drug was the market available Zinnat® 500 mg film coated tablet batch number 747E; manufacturing date June 2019; expiration date June 2022. The test drug was Sharox® 500 mg film coated caplet produced by PT Pratapa Nirmala, batch number FC 0038 manufacturing date March 2021; expiration date March 2023. In the sampling day, subjects were took 1 Cefuroxime 500 mg products of either formulation (reference or test) with 240 mL of water in sitting position as scheduled. Water intake was permitted except during the period of 1 hour before dosing until 2 hours after dosing.
16
 

Inclusion Criteria:

- Willing to sign the informed consent - Healthy male/female (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 laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination), - Age 18 – 55 years, - Body mass index between 18 – 25 kg/m2, - Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 6080 mmHg), heart rate 60 – 90 beats per minute

Exclusion Criteria:

- With history of hypersensitivity to Cefuroxime or other related drug, - With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, - Who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, - Who have participated in any clinical study within 3 month prior the study, - Who have donated or lost 300 mL (or more) of blood within 3 months prior the study, - Who smoke more than 10 sticks of cigarettes a day, - Who have any bleeding or coagulation disorder, - Who 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. Those with history of direct contact with a Covid-19 positive person in the subject neighborhood within last 14 days b. Those with history or present sore throat, fever (with temperature more than 37oC) or short of breath within last 14 days c. Positive to Covid-19 antigen rapid test.
 
KET-895/UN2.F1/ETIK/PPM.00.02/2021
NA
RG.01.02.321.10.21.00415/UB
135/FORM/OMF/2021
apt. Haranissa Dea Oktania