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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Erectile Dysfunction; Pharmacokinetics; Pharmacodynamics
• Intervention / Treatment: Drug: Sildenafil 50 mg Oral Tablet

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)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Sheraton Heliopolis
    • Cairo, Sheraton Heliopolis, Egypt
      • Drug Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects
• Age 18-55 years.
• Ideal weight with ideal body mass index(BMI).
• Non-contributory history and normal physiological examination.
• Laboratory data within normal limits.
• Performance and compliance.
• The subjects should be without known history of alcohol or drug abuse problems
• Subjects who are cigarette smokers
• Subjects who are cannabis smokers
• Subjects who are non-smokers

Exclusion Criteria:

• A known hypersensitivity to the drug.
• Gastrointestinal diseases.
• Auto immune diseases.
• Renal diseases or dysfunction.
• Cardiovascular disease of any type.
• Pancreatic disease including diabetes.
• Hepatic disease.
• Hematological, osteopathic, or pulmonary disease.
• History of alcoholism or drug abuse.
• Serious Psychological illness.
• Positive HIV.
• Abnormal (out of range) laboratory values.
• Subject who have taken any medication less than two weeks of the trials starting date.
• Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Smokers; Subjects administer one tablet of sildenafil 50 mg	Drug: Sildenafil 50 mg Oral Tablet; Sildenafil 50 mg Oral Tablet; Other Names: Viagra 50 mg film coated tablets
Experimental: Cigarette Smokers; Subjects administer one tablet of sildenafil 50mg	Drug: Sildenafil 50 mg Oral Tablet; Sildenafil 50 mg Oral Tablet; Other Names: Viagra 50 mg film coated tablets
Experimental: Cannabis Smokers; Subjects administer one tablet of sildenafil 50mg	Drug: Sildenafil 50 mg Oral Tablet; Sildenafil 50 mg Oral Tablet; Other Names: Viagra 50 mg film coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum drug concentration in plasma (Cmax)	Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)	up to 3 hours post-dose
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)	Area under the plasma concentration-time curve from time 0 to time(t) measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)	up to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Maximum drug concentration in plasma (tmax)	Time corresponding to maximum drug concentration in plasma measured in Hours(h)	up to 3 hours post-dose
Elimination half life of drug in plasma ( t½)	Elimination half life of drug measured in Hours(hr)	Up to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity	Area under the plasma concentration-time curve from time 0 to infinity measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)	Up to 24 hours post-dose

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Drug Research Centre, Cairo, Egypt
• Investigators: Principal Investigator: Nagwa A Sabri, phD, Ainshams university; Principal Investigator: Mohammed M Hussein, Msc student, Ainshams university; Study Director: Mohamed A Raslan, Drug Research Centre, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): June 25, 2019
• Study Completion (Actual): July 8, 2019

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 22, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 22, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: SIL-RES-0119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No