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Completed

NCT Number: NCT04100759

A Comparative Pharmacokinetic and Pharmacodynamic Study 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.

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Key information

Conditions

Erectile Dysfunction Behavior Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Pharmacodynamics Pharmacokinetics Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Smoking Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Drug Research Centre

Cairo, Sheraton Heliopolis, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil 50 mg Oral Tablet

Drug

Sildenafil 50 mg Oral Tablet

Other names: Viagra 50 mg film coated tablets

Primary outcomes

  1. Maximum drug concentration in plasma (Cmax)

    Time frame: up to 3 hours post-dose

    Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)

  2. Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)

    Time frame: up to 24 hours post-dose

    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)

Secondary outcomes

  1. Time to Maximum drug concentration in plasma (tmax)

    Time frame: up to 3 hours post-dose

    Time corresponding to maximum drug concentration in plasma measured in Hours(h)

  2. Elimination half life of drug in plasma ( t½)

    Time frame: Up to 24 hours post-dose

    Elimination half life of drug measured in Hours(hr)

  3. Area under the plasma concentration-time curve from time 0 to infinity

    Time frame: Up to 24 hours post-dose

    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)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Drug Research Centre, Cairo, Egypt

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2019
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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