Bioequivalence Study of Azithromycin Dihydrate 500 mg Film-Coated Caplets Manufactured by PT Medikon Prima Laboratories in Comparison with Zithromax® 500 mg Film-Coated Tablets Manufactured by PT Pfizer Indonesia Under Supervision from Pfizer Inc., New York, NY., USA.
Tahapan Penelitian : Complete
Sponsor:
PT Medikon Prima Laboratories
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-83WLOOH
Tanggal Input Registry : 19-08-2024
Tracking Information | |
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Tanggal Antisipasi Studi | 24-07-2023 |
Outcome Primer | AUC0-t, Cmax |
Outcome Skunder | AUC0-inf , Tmax, T1/2 |
Descriptive Information | |
Judul Penelitian Popular | Bioequivalence Study of Azithromycin Dihydrate 500 mg Film-Coated Caplets Manufactured by PT Medikon Prima Laboratories in Comparison with Zithromax® 500 mg Film-Coated Tablets Manufactured by PT Pfizer Indonesia Under Supervision from Pfizer Inc., New York, NY., USA. |
Judul Penelitian Ilmiah | Bioequivalence Study of Azithromycin Dihydrate 500 mg Film-Coated Caplets Manufactured by PT Medikon Prima Laboratories in Comparison with Zithromax® 500 mg Film-Coated Tablets Manufactured by PT Pfizer Indonesia Under Supervision from Pfizer Inc., New York, NY., USA. |
Jenis Penelitian | Interventional |
Intervensi | Azithromycin Dihydrate 500 mg film-coated caplets |
Jumlah Subyek Penelitian | 32 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: 1. Have read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures 2. Healthy male and female 3. Age between 18 – 55 years 4. Body Mass Index (BMI) between 18–25 kg/m2 5. Having a normal electrocardiogram 6. Resting vital signs (after 10 – 15 minutes of resting) are within the following ranges - Systolic blood pressure: 90 – 129 mmHg - Diastolic blood pressure: 60 – 84 mmHg - Pulse/Heart rate: 60 – 100 beats per minute (based on ESC - ESH Guidelines for the Management of Arterial Hypertension (2018)) 7. Having no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.Exclusion Criteria: 1. Pregnant and/or nursing woman. 2. Having history of hypersensitivity or contraindication to azithromycin dihydrate, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction 3. Having history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease. 4. Having history or presence of any coagulation disorder or clinically significant hematology abnormalities. 5. Disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout study period. 6. Using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day. 7. Participate in any clinical study within the past 90 days prior to the study. 8. Having donation or lost 300 mL (or more) of blood within 3 months prior to the study. 9. Smoking habit with more than 10 cigarettes a day. 10. History of travelling to another city within the last 14 days without following health authority regulation. 11. History of direct contact with a COVID-19 positive person in the subject’s neighborhood within 5 days prior to screening. 12. History or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days. 13. Positive result for SARS CoV-2 antigen test. 14. Positive result for HIV, HBsAg, and HCV tests (to be kept confidential). 15. History of drug or alcohol abuse within 12 months prior to screening for this study. 16. Subjects who unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access. |
Administrative Information | |
Nomor Persetujuan Etik | KET-505/UN.2.F1/ETIK/PPM.00.02/2023 and S-327/UN.2.F1/ETIK/PPM.00.02/2023 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | |
Contact Person | apt. Juliana, S.Farm., M.Farm |