Bioequivalence Study of Favipirafir 200 mg Film Coated Tablets Produced by PT. Kimia Farma Tbk Compared to Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-TWPETGQ
Tanggal Input Registry : 16-08-2023

13-04-2022
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration); 15 minutes, 30 minutes, 45 minutes, 60 minutes, 80 minutes, 100 minutes and 2; 2.5; 3; 3.5; 4; 5; 6; 8; 12; and 24 hours after drug administration (17 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); 15 minutes, 30 minutes, 45 minutes, 60 minutes, 80 minutes, 100 minutes and 2; 2.5; 3; 3.5; 4; 5; 6; 8; 12; and 24 hours after drug administration (17 time points) after drug administration] 90% Confidence Interval (80-125)
 
Bioequivalence Study of Favipirafir 200 mg Film Coated Tablets Produced by PT. Kimia Farma Tbk Compared to Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd
Bioequivalence Study of Favipirafir 200 mg Film Coated Tablets Produced by PT. Kimia Farma Tbk Compared to Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd
Interventional
The reference drug was Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd, batch number HG2101A, expired date on Juli 2023. The test drug was Favipiravir 200 mg Tablet produced by PT Kimia Farma Tbk, batch number G10110N, manufacturing date July 27th 20221 Expired date July 27th 2022. In sampling day, subject took one dose of Favipiravir manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying 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 or 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 within the normal range according to 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; g. Willing to use contraceptives during the bioequivalence test period until 7 days after the test.

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 before screening and before administering the test drug or comparator; c. Have a history of kidney, liver disease, and have a history of allergy or hypersensitivity or contraindications to the bioequivalence test drug (Favipiravir); 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.
 
KET-161/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T