Bioequivalence Study of Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-5WPGEH3
Tanggal Input Registry : 18-08-2023

19-10-2021
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration); 1; 2; 3; 3,5; 4; 4,5; 5; 5,5; 6; 8; 10; 12; 16; 24; 36; 48; and 72 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); 1; 2; 3; 3,5; 4; 4,5; 5; 5,5; 6; 8; 10; 12; 16; 24; 36; 48; and 72 hours after drug administration (18 time points) after drug administration] 90% Confidence Interval (80-125)
 
Bioequivalence Study of Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia
Bioequivalence Study of Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia
Interventional
The reference drug was Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia, batch number 424T, manufacturing date on December 2019, expired date on November 2021. The test drug was Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk, batch number A00035NX, manufacturing date January 2020, Expired date January 2022. In sampling day, subject took one dose of Salbutamol 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 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 within the normal range according to Body Mass Index (BMI) 18 - 25 kg/m2; f. Vital signs are 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 check the heart rate breathing 12-20 breaths/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 at the time of screening and before administering the test drug or comparator; c. Have a history of kidney, liver and have a history of allergies or hypersensitivity or contraindications to the drug bioequivalence test (Salbutamol); 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 200 ml within 3 months of the start of the study.
 
01/21.06/01080
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T