Bioequivalence Study of 100 mg Ericfil ® Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Viagra ® 100 mg Film Coated Tablets Produced by Pfizer, France

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
Tanggal Input Registry : 23-05-2023

08-11-2017
The primary objective of this study was to establish the bioequivalence of 100 mg Ericfil® film coated tablets produced by PT. Novell Pharmaceutical Laboratories in comparison with Viagra® 100 mg film coated tablets produced by Pfizer, France.
Tolerance assessment was not a major objective in this study. However, comparison of tolerance between the two products is a secondary objective. The criteria of safety would include any adverse reactions or significant abnormal laboratory values, or abnormal physical examinations or vital signs measurements recorded during the study. Any of these observations would be documented in the subject’s Case Report Form(CRF).
 
Bioequivalence Study of 100 mg Ericfil ® Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Viagra ® 100 mg Film Coated Tablets Produced by Pfizer, France
Bioequivalence Study of 100 mg Ericfil ® Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Viagra ® 100 mg Film Coated Tablets Produced by Pfizer, France
Interventional
The reference drug was VIAGRA ® film-coated tablets (100 mg Sildenafil), Lot Number A325402B; Manufacturing date unknown; Expiry date February 2018; manufactured by Pfizer, France. The test drug was Ericfil ® film-coated tablets (100 mg Sildenafil), Batch Number 18L245; Manufacturing date November 2016; Expired Date November 2018; produced by PT Novell Pharmaceutical Laboratories. Each subject received a single oral dose of one FC tablet of 100 mg Ericfil® or Viagra® after an overnight fast for at least 10 hours. The dose was taken at ± 07.00 am with 240 ml of water. Water intake was allowed one hour before and one hour after the dose.
24
 

Inclusion Criteria:

1.Healthy male subjects, age between 18 to 55 years old 2.Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2) 3.Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm) 4.Give a written informed consent 5.Acceptable medical history and physical examination 6.Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR). 7.Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, fasting glucose, total cholesterol, blood urea nitrogen, ureum, creatinine. 8.Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria). 9.Acceptable electrocardiogram (ECG) result. Initial ECG will be required from subjects who have never participated in BA/BE study at Clinisindo. ECG will be required every six months from subjects who have previously participated in a BA/BE study at Clinisindo. 10.Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV) 11.Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine

Exclusion Criteria:

1.Smoker. If necessary, light smoker (≤5 cigarettes/day) can be accepted. 2.Have history of hepatic, cardiovasculer, gastrointestinal or renal disease. 3.Have history of severe hepatic impairment, hypotension (blood pressure 170/110 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa. 4.Using nitric oxide donors, organic nitrate or organic nitrate in any forms, both acute and chronic nitrate administration. (1) 5.Potentially sensitive to this type medication or hypersensitive to sildenafil. 6.History of alcohol, drug abuse within 12 months prior to screening for this study. 7.Received any other medications within fourteen days prior to the start of the study, especially glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any forms, ketoconazole, cimetidine, erythromycin, saquinavir, ritonavir, rifampicin, and alpha-blocker drugs.(1) 8.Participated in any clinical study within 3 months after the date of completion. 9.Donation or loss more than 450 mL of blood within 3 months prior to the screening of the study.
 
625/UN2.F1/ETIK/VI/2017
CLXXVII/057/CL/2017
Edria Rasendriya