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

NCT ID: NCT04100759

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2019-07-08

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)

Conditions

Erectile Dysfunction; Smoking; Pharmacokinetics; Pharmacodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-Smokers

Subjects administer one tablet of sildenafil 50 mg

Group Type: EXPERIMENTAL

Sildenafil 50 mg Oral Tablet

Intervention Type: DRUG

Sildenafil 50 mg Oral Tablet

Cigarette Smokers

Subjects administer one tablet of sildenafil 50mg

Group Type: EXPERIMENTAL

Sildenafil 50 mg Oral Tablet

Intervention Type: DRUG

Sildenafil 50 mg Oral Tablet

Cannabis Smokers

Subjects administer one tablet of sildenafil 50mg

Group Type: EXPERIMENTAL

Sildenafil 50 mg Oral Tablet

Intervention Type: DRUG

Sildenafil 50 mg Oral Tablet

Interventions

Sildenafil 50 mg Oral Tablet

Sildenafil 50 mg Oral Tablet

Intervention Type: DRUG

Other Intervention Names

Viagra 50 mg film coated tablets

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Drug Research Centre, Cairo, Egypt

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Raslan

QC Manager and Clinical pharmacy Msc student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagwa A Sabri, phD

Role: PRINCIPAL_INVESTIGATOR

Ainshams university

Mohammed M Hussein, Msc student

Role: PRINCIPAL_INVESTIGATOR

Ainshams university

Mohamed A Raslan

Role: STUDY_DIRECTOR

Drug Research Centre, Cairo, Egypt

Locations

Drug Research Centre

Cairo, Sheraton Heliopolis, Egypt

Countries

Egypt

Other Identifiers

SIL-RES-0119

Identifier Type: -

Identifier Source: org_study_id