Bioequivalence Study of Ethambutol 400 mg Entericcoated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 400 mg Film-Coated Tablet Manufactured by Pantheon Inc, Ontario, Canada, for STI Pharma Llc

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-R1L9TCM
Tanggal Input Registry : 10-08-2023

31-05-2023
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration), 0.33 ; 0.67 ; 1 ; 1.5 ; 2 ; 2.5 ; 3 ; 3.5 ; 4 ; 5 ; 6 ; 8 ; 10 ; 12 ; 16 ; 24 and 36 jam hours after drug administration (18 time points) after drug administration] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 24 hours (AUCt) [[time points : 0 hours (before drug administration), 0.33 ; 0.67 ; 1 ; 1.5 ; 2 ; 2.5 ; 3 ; 3.5 ; 4 ; 5 ; 6 ; 8 ; 10 ; 12 ; 16 ; 24 and 36 jam hours after drug administration (18 time points) after drug administration] 90% Confidence Interval (80-125)
 
Bioequivalence Study of Ethambutol 400 mg Entericcoated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 400 mg Film-Coated Tablet Manufactured by Pantheon Inc, Ontario, Canada, for STI Pharma Llc
Bioequivalence Study of Ethambutol 400 mg Entericcoated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 400 mg Film-Coated Tablet Manufactured by Pantheon Inc, Ontario, Canada, for STI Pharma Llc
Interventional
The reference drug was Myambutol Film-Coated Tablet 400 mg produced by Pantheon Inc, Ontario, Canada for STI Pharma Llc, batch number CFKFD, expired date on November 2023. The test drug was Ethambutol 400 mg Tablet produced by PT Kimia Farma Tbk, batch number J20113NX, Expired date October 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position.
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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-185/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T