A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Sildenafil 100 mg Film-coated Tablets (Xegra 100) and Reference Product (VIAGRA) in Healthy Thai Male Volunteers under Fasting Conditions

Not Applicable

Completed

• Conditions: Sildenafil concentration in plasma; Sildenafil citrate tablet; Bioequivalence

• Registration Number: TCTR20180709001
• Lead Sponsor: International Bio Service Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-09
• Study Completion: 2018-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

1.Healthy Thai male subjects between the ages of 18 to 55 years
2.Body mass index between 18.0 to 30.0 kg/m2
3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
4.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study in Period 2
5.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

Exclusion Criteria

1. History of allergic reaction or hypersensitivity to sildenafil, tadalafil, vardenafil or other selective inhibitors of PDE-5 or any of the excipients of this product
2.History or evidence of clinically significant renal, hepatic, gastrointestinal,hematological (e.g. anemia, leukemia), endocrine (e.g. thyroid), pulmonary or respiratory (e.g., asthma), cardiovascular, psychiatric , neurologic (e.g. convulsion,
depression, insomnia), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
3.History or evidence of cardiovascular disorder e.g., cardiac failure, stroke,myocardial infarction, aortic stenosis, cardiac myopathy, uncontrolled blood pressure, unstable angina, headache, migraine, vertigo
4.History or evidence of vision disorder or genetic vision disorder e.g., decreased vision or loss of vision, night blindness
5.Have anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis,Peyronie's disease) or have conditions which may predispose them to priapism
6.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
7.History of problems with swallowing tablet or capsule
8.History of sensitivity to heparin or heparin-induced thrombocytopenia
9.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy,gastritis or duodenal or gastric ulceration other than appendectomy
10.History of preceding diarrhea within 24 hours prior to admission in each period
11.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
12.Have renal creatinine clearance (Clcr) < 30 mL/min based on serum creatinine results at the screening laboratory test
13.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec,or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject’s eligibility.
14.Investigation with blood sample shows positive test for HBsAg.
15.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
16.Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and on the day of admission in each period. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject’s eligibility.
17.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
18.History or evidence of alcoholism, regular alcohol consumption or alcohol containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
19.History or evidence of habitual c

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sildenafil concentration in plasma, Cmax, AUC0-tlast and AUC0-inf. Within 24 after taking sildenafil tablet Liquid chromatography-mass spectrometry method and statistical analysis

Secondary Outcome Measures

Name	Time	Method
Sildenafil concentration in plasma, Tmax, AUC0-tlast/AUC0-inf., AUC%extrapolate Within 24 after taking sildenafil tablet Liquid chromatography-mass spectrometry method and statistical analysis