Trial | NCT04100759  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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.
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 Started
Jun 11
2019
Primary Completion
Jun 25
2019
Study Completion
Jul 08
2019
Last Update
Sep 24
2019

Drug Sildenafil 50 mg Oral Tablet

Sildenafil 50 mg Oral Tablet

  • Other names: Viagra 50 mg film coated tablets

Non-Smokers Experimental

Subjects administer one tablet of sildenafil 50 mg

Cigarette Smokers Experimental

Subjects administer one tablet of sildenafil 50mg

Cannabis Smokers Experimental

Subjects administer one tablet of sildenafil 50mg

Criteria 

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.
No Results Posted