Clinical trial NCT04100759: A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers
Official title: Pharmacokinetics and Pharmacodynamics of Sildenafil in Adult Smokers and Non-smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Erectile Dysfunction
Smoking
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Drug Research Centre, Cairo, Egypt
First posted: 2019-09-24
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility 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.

Primary outcomes:
measure: Maximum drug concentration in plasma (Cmax)
timeFrame: up to 3 hours post-dose
measure: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)
timeFrame: up to 24 hours post-dose
Secondary outcomes:
measure: Time to Maximum drug concentration in plasma (tmax)
timeFrame: up to 3 hours post-dose
measure: Elimination half life of drug in plasma ( t½)
timeFrame: Up to 24 hours post-dose
measure: Area under the plasma concentration-time curve from time 0 to infinity
timeFrame: Up to 24 hours post-dose
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Drug Research Centre
state: Sheraton Heliopolis
Study officials:
affiliation: Ainshams university
name: Nagwa A Sabri, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ainshams university
name: Mohammed M Hussein, Msc student
role: PRINCIPAL_INVESTIGATOR
affiliation: Drug Research Centre, Cairo, Egypt
name: Mohamed A Raslan
role: STUDY_DIRECTOR
References: