Bioequivalence Study of 200 mg/5 mL Azithromycin Dihydrate Dry Syrup, Manufactured by PT Pharos Indonesia (Aztrin®) in Comparison with the Reference Dry Syrup (Zithromax®), Manufactured by Haupt Pharma Latina S.r.l., Italy, Imported by PT Pfizer Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Pharos Indonesia
Mitra Pelaksana:
Econolab
No Registry
INA-3LXCTQD2
Tanggal Input Registry : 30-06-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 21-04-2025 |
| Outcome Primer | AUC0-t, Cmax |
| Outcome Skunder | AUC0-inf, tmax, t1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 200 mg/5 mL Azithromycin Dihydrate Dry Syrup, Manufactured by PT Pharos Indonesia (Aztrin®) in Comparison with the Reference Dry Syrup (Zithromax®), Manufactured by Haupt Pharma Latina S.r.l., Italy, Imported by PT Pfizer Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of 200 mg/5 mL Azithromycin Dihydrate Dry Syrup, Manufactured by PT Pharos Indonesia (Aztrin®) in Comparison with the Reference Dry Syrup (Zithromax®), Manufactured by Haupt Pharma Latina S.r.l., Italy, Imported by PT Pfizer Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | 5 mL of reconstituted Aztrin® Dry Syrup (equivalent to 200 mg Azithromycin) in single dose |
| Jumlah Subyek Penelitian | 34 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the Investigators and agree to sign an informed consent; Willing to use contraception (condoms) when having intercourse with spouse during the study; Healthy male/female subjects as determined by the medical screening assessments; Aged 18-55 years; Body mass index (BMI) within the range of 18-25 kg/m²; Normal blood pressure (systolic 90-120 mmHg; diastolic 60-80 mmHg); Normal pulse rate (60-100 bpm, based on ECG examination); Normal electrocardiogram (ECG); Clinical laboratory results within normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test was applied to female subjects when screening and just before taking the test or reference drug); Known hypersensitivity or contraindication to the study drug; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day; History of any bleeding or coagulation disorders; Any surgical or medical history (present or past) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g., gastrointestinal diseases including gastric or duodenal ulcers, or history of gastric surgery; A donation or loss of 300 mL (or more) of blood within 90 days months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within 12 months prior to this study; Heavy smoker (more than 10 cigarettes a day); Had a clinically significant bleeding within 90 days prior to the study; Participation in a previous study within 90 days of this study’s first dosing day. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1211/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 | PRO-279/24/ECL |
| Contact Person | Ni Made Dwi Wulandari |