Bioequivalence Study of Azithromycin 500 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk Compared to Zithromax® 500 mg Film-Coated Tablets Manufactured by PT. Pfizer Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-ROT77EZ
Tanggal Input Registry : 28-08-2023

03-06-2023
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration); 20 minutes; 40 minutes; 1 hour; 1.33 hours; 1.66 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 5 hours; 6 hours; 8 hours; 12 hours; 24 hours; 48 hours; and 72 hours after drug administration (17-time points)] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 12 hours (AUCt) [[time points: 20 minutes; 40 minutes; 1 hour; 1.33 hours; 1.66 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 5 hours; 6 hours; 8 hours; 12 hours; 24 hours; 48 hours; and 72 hours after drug administration (17-time points)] 90% Confidence Interval (80-125)
 
Bioequivalence Study of Azithromycin 500 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk Compared to Zithromax® 500 mg Film-Coated Tablets Manufactured by PT. Pfizer Indonesia
Bioequivalence Study of Azithromycin 500 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk Compared to Zithromax® 500 mg Film-Coated Tablets Manufactured by PT. Pfizer Indonesia
Interventional
The reference drug was Zithromax® 500 mg Film-Coated Tablets produced by PT. Pfizer Indonesia, batch number A200168, manufacturing date on September 2020, expired date on August 2024. The test drug was Azithromycin 500 mg fil-coated Tablet produced by PT Kimia Farma Tbk, batch number J03K2403, manufacturing date November 2022, Expired date October 2024. On the sampling day, the subject took one dose of azithromycin manufactured of either formulation (reference or test) as per the randomization scheme with 220 ml water in a seated position.
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Inclusion Criteria:

Inclusion criteria in this study include: a. Sign informed consent b. Healthy, based on clinical laboratory tests (routine hematology, liver function, kidney function, blood sugar, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination; c. Male and female subjects (if female, consider the risk in women of childbearing age and take a pregnancy test); d. Age between 18 - 55 years; e. Body weight is within the normal range according to the Body Mass Index (BMI) 18 - 25 kg/𝑚2; f. Vital signs were in the following range systolic blood pressure 110 - 129 mmHg, diastolic blood pressure 70 - 84 mmHg, pulse within the normal range 60 - 90 bpm, check oxygen saturation (SpO2) within the normal range 95-100%, and heart rate breathing within the normal range of 12-20/min;

Exclusion Criteria:

Exclusion criteria in this study include: a. Smoking more than 10 cigarettes per day; b. Pregnant or nursing women. A pregnancy test is carried out first at the time of screening and before administering the test drug or comparator c. Have a history of kidney and liver disease, and have a history of allergies or hypersensitivity or contraindications to the bioequivalence test drug (Lansoprazole); d. Clinically significant haematological abnormalities; e. Electrocardiogram (ECG) abnormalities; f. Difficulty in venous accessibility in the left or right arm; g. History of ongoing serious illness or chronic disease that is clinically or medically significant; h. History of drug or alcohol abuse in the 12 months (1 year) prior to screening for this study; i. Positive serological tests include Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV); j. The test result of the SARS-CoV-2 antigen rapid test is positive (if the BE test is carried out during a pandemic); k. Have a history or condition that may affect the kinetics of the drug; l. Using drugs or food supplements no more than 7 days since the study began; m. Participated in a previous clinical trial no later than 3 months from the time the study started; n. Blood donation or blood loss of more than 300 ml less than 3 months from the start of the study.
 
S-203/UN.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T