Bioequivalence Study of 500 mg Azithromycin Film Coated Caplets, Manufactured by PT. Prima Medika Laboratories (Aztrin®), Registered by PT. Pharos Indonesia in Comparison with the Innovator’s Film Coated Tablets (Zithromax®), Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, Under Supervision of Pfizer Inc. New York, N.Y., U.S.A.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
No Registry
INA-DMA8KOH
Tanggal Input Registry : 30-08-2023

14-09-2022
AUC0-t dan Cmax
 
Bioequivalence Study of 500 mg Azithromycin Film Coated Caplets, Manufactured by PT. Prima Medika Laboratories (Aztrin®), Registered by PT. Pharos Indonesia in Comparison with the Innovator’s Film Coated Tablets (Zithromax®), Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, Under Supervision of Pfizer Inc. New York, N.Y., U.S.A.
Bioequivalence Study of 500 mg Azithromycin Film Coated Caplets, Manufactured by PT. Prima Medika Laboratories (Aztrin®), Registered by PT. Pharos Indonesia in Comparison with the Innovator’s Film Coated Tablets (Zithromax®), Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, Under Supervision of Pfizer Inc. New York, N.Y., U.S.A.
Interventional
All subjects were fasted start from 09.00 p.m. to drug administration. On the next day, physician instructed subjects to consume 1 film coated caplet of test product or 1 film coated tablet product with 240 mL of water or equivalent to a glass of mineral water. Before given to subjects, test or reference drug was mixed completely. Investigator were onsite to ensure that each subject swallows the study products. Physician ensured that each subject swallowed the study products.
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Inclusion Criteria:

Able to participate, communicate well with the investigators and agree to sign an informed consent, Willing to use contraception (condoms) when intercourse with spouse during the study, Healthy male/female subjects as determined by the medical screening assessments, Aged 18-55 years of age, Body mass index (BMI) is in the range of 18-25 kg/m², Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg); normal pulse rate 60-90 bpm, Normal electrocardiogram (ECG), and Clinical laboratory results have to be within normal range.

Exclusion Criteria:

Pregnant or lactating women (urinary pregnancy test to be applied to female subjects when screening and just before taking the test or innovator 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 condition (present or history) 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 3 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), Clinically have significant bleeding within 3 months prior to the study, Participation in a previous study within 3 months of this study’s first dosing day, A positive nasopharyngeal swab SARS-CoV2 (Covid-19) antigen rapid test result. Covid-19 antigen rapid test to be applied to all subjects when screening and one day before drug administration in each period of study.
 
KET-462/UN2.F1/ETIK/PPM.00.02/2021
MTA number
PPUK/PPUB number
Ni Made Dwi Wulandari, S.KM.