Bioequivalence study of Zibramax (500 mg Azithromycin) film coated caplet produced by PT Guardian Pharmatama in comparison with Zithromax (500 mg Azithromycin) film coated tablet manufactured by PT Pfizer Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Guardian Pharmatama
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-D4HEQMP
Tanggal Input Registry : 14-07-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 21-05-2022 |
| Outcome Primer | AUC0-t dan Cmax |
| Outcome Skunder | AUC0-∞, t1/2, dan tmax |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Zibramax (500 mg Azithromycin) film coated caplet produced by PT Guardian Pharmatama in comparison with Zithromax (500 mg Azithromycin) film coated tablet manufactured by PT Pfizer Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence study of Zibramax (500 mg Azithromycin) film coated caplet produced by PT Guardian Pharmatama in comparison with Zithromax (500 mg Azithromycin) film coated tablet manufactured by PT Pfizer Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was the market available Zithromax® (500 mg Azithromycin) film coated tablet manufactured by PT. Pfizer Indonesia, batch number A210081; manufacturing date on April 2021; expiration date on March 2025. The test drug was Zibramax (500 mg Azithromycin) film coated caplet produced by PT. Guardian Pharmatama, batch number T210717; manufacturing date on 21st July 2021; expiration date on July 2023. In the sampling day, subjects took 1 dose of Azithromycin products of either formulation (reference or test) with 240 mL of water in sitting position as scheduled. Water intake was permitted except during 1 hour before dosing until 2 hours after dosing. |
| Jumlah Subyek Penelitian | 32 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Willing to sign the informed consent, - 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, - Healthy male (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).Exclusion Criteria: - Contraindicated and/or has history of hypersensitivity to Azithromycin or 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, - Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, - Participated in any clinical study within 3 months prior the study, - Donated or lost 300 mL (or more) of blood within 3 months prior the study, - Smoke more than 9 sticks of cigarettes a day, - Have any bleeding or coagulation disorder, - 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 below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days, b. With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-338/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 146/FORM/OMF/2022 |
| Contact Person | apt. Haranissa Dea Oktania |