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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04100759
• Other study ID #: SIL-RES-0119
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 11, 2019
• Est. completion date: July 8, 2019

Study information

• Verified date: September 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 8, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Pharmacodynamics
• Pharmacokinetics
• Smoking

Intervention

Drug:
• Sildenafil 50 mg Oral Tablet
Sildenafil 50 mg Oral Tablet

Locations

Country	Name	City	State
Egypt	Drug Research Centre	Cairo	Sheraton Heliopolis

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Drug Research Centre, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Elimination half life of drug in plasma ( t½)	Elimination half life of drug measured in Hours(hr)	Up to 24 hours post-dose
Secondary	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