Bioequivalence Study of Sildenafil Film Coated Tablets 100 mg Produced by PT. Kimia Farma Tbk. Compared to Viagra 100 mg Film-Coated Tablets Produced by Pfizer

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
In conducting this research, we collaborated with several partners, there are : 1. Ambulance Gawat Darurat Dinas Kesehatan DKI Jakarta to provide ambulance and paramedical services for emergencies 2. Clinical Laboratory - PT Kimia Farma Diagnostika to carry out medical check-ups 3. Mintohardjo Naval Hospital as a reference for subjects who experienced an adverse event 4. Competent phlebotomist for blood sampling during the study, and 5. Doctor for monitoring vital signs of research subjects
No Registry
Tanggal Input Registry : 15-06-2023

24-06-2022
1. Maximum plasma concentration (Cmax) [ Time Frame: before dosing (0 hour) and at 10, 20, 30, 45, 60 minutes, and 1,5;2; 2,5; 3; 4; 6; 9; 12; 16; and 24 hours after drug administration ] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 24 hours (AUCt) [ Time Frame: before dosing (0 hour) and at 10, 20, 30, 45, 60 minutes, and 1,5;2; 2,5; 3; 4; 6; 9; 12; 16; and 24 hours after drug administration ] 90% Confidence Interval (80-125)
1. Maximum plasma concentration (Cmax) [ Time Frame: before dosing (0 hour) and at 10, 20, 30, 45, 60 minutes, and 1,5;2; 2,5; 3; 4; 6; 9; 12; 16; and 24 hours after drug administration ] Pharmacokinetics Parameter 2. Area Under Curve from 0 to 24 hours (AUCt) [ Time Frame: before dosing (0 hour) and at 10, 20, 30, 45, 60 minutes, and 1,5;2; 2,5; 3; 4; 6; 9; 12; 16; and 24 hours after drug administration ] Pharmacokinetics Parameter
 
Bioequivalence Study of Sildenafil Film Coated Tablets 100 mg Produced by PT. Kimia Farma Tbk. Compared to Viagra 100 mg Film-Coated Tablets Produced by Pfizer
Bioequivalence Study of Sildenafil Film Coated Tablets 100 mg Produced by PT. Kimia Farma Tbk. Compared to Viagra 100 mg Film-Coated Tablets Produced by Pfizer
Interventional
The reference drug was Viagra (100 mg Sildenafil) film-coated tablet manufactured by Pfizer batch number B568310, manufacturing date October 2020; expiration date on September 2023. The test drug was Sildenafil (100 mg Sildenafil) film-coated tablet produced by PT Kimia Farma Tbk, batch number FP03.L2129.088; manufacturing date on 29 December 2021; expiration date on 29 December 2023. Subjects were given one dose (1 tablet) of Sildenafil products of either formulation (reference or test), as per randomization scheme with 220 mL of water in a sitting position.
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Inclusion Criteria:

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 subject; d) Age between 18 - 55 years; e) Body weight within the normal range according to the Body Mass Index (BMI) 18 - 25 kg/m^2; 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:

a) Smoking more than 10 cigarettes per day; b) Have a history of kidney and liver disease, and have a history of allergies or hypersensitivity or contraindications to the bioequivalence test drug (Sildenafil); c) Clinically significant hematological abnormalities; d)Electrocardiogram (ECG) abnormalities; e) Difficulty in venous accessibility in the left or right arm; f) History of ongoing serious illness or chronic disease that is clinically or medically significant; g) History of drug or alcohol abuse in the 12 months (1 year) prior to screening for this study; h) Positive serological tests include Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV); i) The test result of the SARS-CoV-2 antigen rapid test is positive (if the BE test is carried out during a pandemic); j) Have a history or condition that may affect the kinetics of the drug; k) Using drugs or food supplements no more than 7 days since the study began; l) Participated in a previous clinical trial no later than 3 months from the time the study started; m) Blood donation or blood loss of more than 300 ml less than 3 months from the start of the study.
 
KET-429/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
012/BE/EQL/APR-2022
Nungky Tri Yunica, S.T