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

Ain Shams University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pharmacodynamics; Erectile Dysfunction; Smoking; Pharmacokinetics

Treatments: Drug: Sildenafil 50 mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04100759

SIL-RES-0119

Details and patient eligibility

About

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.

Full 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)

Enrollment: 36 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Non-Smokers

Experimental group

Description:

Subjects administer one tablet of sildenafil 50 mg

Treatment:

Drug: Sildenafil 50 mg Oral Tablet

Cigarette Smokers

Experimental group

Description:

Subjects administer one tablet of sildenafil 50mg

Treatment:

Drug: Sildenafil 50 mg Oral Tablet

Cannabis Smokers

Experimental group

Description:

Subjects administer one tablet of sildenafil 50mg

Treatment:

Drug: Sildenafil 50 mg Oral Tablet