Bioequivalence Study of Ethambutol 500 mg Film-coated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 5x100 mg Film-coated Tablet Manufactured by Labatec Pharma S.A, Meyrin Geneva Swiss

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
EQuitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-ZMWGFQR
Tanggal Input Registry : 22-01-2024

24-11-2023
AUC0-t , Cmax
AUC0-inf , Tmax, Half life
 
Bioequivalence Study of Ethambutol 500 mg Film-coated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 5x100 mg Film-coated Tablet Manufactured by Labatec Pharma S.A, Meyrin Geneva Swiss
BIOEQUIVALENCE STUDY OF ETHAMBUTOL 500 MG FILM-COATED TABLET MANUFACTURED BY PT. KIMIA FARMA Tbk COMPARED TO MYAMBUTOL 5x100 MG FILM-COATED TABLET MANUFACTURED BY LABATEC PHARMA S.A, MEYRIN GENEVA SWISS
Interventional
Ethambutol 500 mg Film-coated Tablet Manufactured by PT. Kimia Farma Tbk
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Inclusion Criteria:

The inclusion criteria for this study include: 1) Signed informed consent; 2) Healthy based on clinical laboratory tests (routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV), and HIV (Anti-HIV), medical history, and physical examination); 3) Male and female subjects (if female, consider the risks for women of childbearing age and perform pregnancy tests); 4) Age between 18-55 years; 5) Normal weight range according to Body Mass Index (BMI) 18-25 kg/m2 ); 6) Vital signs within the following ranges: systolic blood pressure 110- 129 mmHg, diastolic blood pressure 70-84 mmHg, normal pulse rate 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95- 100%, and normal respiratory rate of 12-20/min.

Exclusion Criteria:

The exclusion criteria for this study include: 1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests was performed during screening and prior to the administration of the investigational or comparator drug; 3) History of kidney or liver disease, or history of allergy, hypersensitivity or contraindication to the investigational bioequivalence drug (Ethambutol); 4) Clinically significant hematological abnormalities; 5) Abnormal electrocardiogram (ECG); 6) Difficulty accessing veins in the left or right arm; 7) History of significant ongoing clinically or medically significant chronic or acute illness; 8) History of drug or alcohol abuse within the past 12 months (1 year) prior to screening for this study; 9) Positive serology test results for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV). 10) Positive rapid antigen test results for SARS-CoV-2 (if the BE study is conducted during a pandemic). 11) History or condition that can affect drug kinetics. 12) Use of drugs or dietary supplements no more than 7 days since the start of the study. 13) Participation in previous clinical trials no more than 3 months from the start of the study. 14) Blood donation or blood loss of more than 300 ml within 3 months from the start of the study
 
KET-1425/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Bayu Hadi Wahyono, Pharm, B.Pham, MPH - Study Coordinator (085773150080 - lab.equitrust@gmail.com)