NCT04100759

A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers

Pharmacokinetics and Pharmacodynamics of Sildenafil in Adult Smokers and Non-smokers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.

Detailed description

The study is a randomized, single dose, one way, open label, parallel study in thirty-six (36) subjects randomized into three groups;group(1) included twelve(12) healthy non-smoker males, group(2) included twelve(12) healthy smokers (Cigarettes) and group(3) included twelve(12) healthy smokers (marijuana). Each group received a single dose of Viagra 50 mg film coated tablet (Sildenafil 50 mg) Blood samples were collected at the following sampling intervals: pre-dose administration, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8,10, 12 and 24 hours post dose. Blood samples were centrifuged and plasma was separated and stored at -80 degree Celsius till time of analysis. Plasma concentrations of sildenafil were determined by liquid chromatography tandem mass spectrometry (LC/MS/MS)

Conditions

• Erectile Dysfunction
• Smoking
• Pharmacokinetics
• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Sildenafil 50 mg Oral Tablet	Sildenafil 50 mg Oral Tablet

Timeline

• Start date: 2019-06-11
• Primary completion: 2019-06-25
• Completion: 2019-07-08
• First posted: 2019-09-24
• Last updated: 2019-09-24

Locations

1 site across 1 country: Egypt