BIOEQUIVALENCE STUDY OF AZITHROMYCIN 500 MG FILM COATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK 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 Kimia Farma Tbk
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-T1ZMGLX
Tanggal Input Registry : 10-10-2024
Tracking Information | |
---|---|
Tanggal Antisipasi Studi | 29-07-2024 |
Outcome Primer | AUC0-t , Cmax |
Outcome Skunder | AUC0-inf , Tmax, Half life |
Descriptive Information | |
Judul Penelitian Popular | BIOEQUIVALENCE STUDY OF AZITHROMYCIN 500 MG FILM COATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK 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 500 MG FILM COATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK 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 500 mg film-coated tablets manufactured by PT Kimia Farma Tbk. |
Jumlah Subyek Penelitian | 34 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: 1. Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures 2. Subjects were healthy male and female 3. Subjects’ age ranges from 18 – 55 years 4. Subjects’ body mass index between 18 – 25 kg/m2 5. Subjects had a normal electrocardiogram 6. Subjects had resting vital signs (after 10 – 15 minutes of resting) were 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. Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening 8. Have received the complete primary SARS CoV-2 vaccine.Exclusion Criteria: 1. those who were pregnant and/or nursing condition 2. those with a history of hypersensitivity or contraindication to azithromycin, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction 3. those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, active peptic ulcer, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease 4. those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities 5. those who disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period 6. those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day 7. those who had participated in any clinical study within the past 90 days prior to the study 8. those who had donated or lost 300 mL (or more) of blood within 3 months prior to the study 9. those who were smoker 10. those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days prior to screening 11. those with a history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea with in the last 14 days 12. those who were positive result for HIV, HbsAg, and HCV tests (to be kept confidential) 13. those were had history of drug or alcohol abuse within 12 months prior to screening for this study 14. those who were 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-964/UN2.F1/ETIK/PPM.00.02/2024 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | |
Contact Person | Nabila Mudin Susanto, PT Pharma Metric Labs, email : nabila.susanto@pharmametriclabs.com, Tel : +62 21 4265310 |