A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers
Primary Purpose
Erectile Dysfunction, Smoking, Pharmacokinetics
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil 50 mg Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
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.
Sites / Locations
- Drug Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Non-Smokers
Cigarette Smokers
Cannabis Smokers
Arm Description
Subjects administer one tablet of sildenafil 50 mg
Subjects administer one tablet of sildenafil 50mg
Subjects administer one tablet of sildenafil 50mg
Outcomes
Primary Outcome Measures
Maximum drug concentration in plasma (Cmax)
Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)
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)
Secondary Outcome Measures
Time to Maximum drug concentration in plasma (tmax)
Time corresponding to maximum drug concentration in plasma measured in Hours(h)
Elimination half life of drug in plasma ( t½)
Elimination half life of drug measured in Hours(hr)
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)
Full Information
NCT ID
NCT04100759
First Posted
September 12, 2019
Last Updated
September 22, 2019
Sponsor
Ain Shams University
Collaborators
Drug Research Centre, Cairo, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04100759
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
July 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Drug Research Centre, Cairo, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Smoking, Pharmacokinetics, Pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Smokers
Arm Type
Experimental
Arm Description
Subjects administer one tablet of sildenafil 50 mg
Arm Title
Cigarette Smokers
Arm Type
Experimental
Arm Description
Subjects administer one tablet of sildenafil 50mg
Arm Title
Cannabis Smokers
Arm Type
Experimental
Arm Description
Subjects administer one tablet of sildenafil 50mg
Intervention Type
Drug
Intervention Name(s)
Sildenafil 50 mg Oral Tablet
Other Intervention Name(s)
Viagra 50 mg film coated tablets
Intervention Description
Sildenafil 50 mg Oral Tablet
Primary Outcome Measure Information:
Title
Maximum drug concentration in plasma (Cmax)
Description
Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)
Time Frame
up to 3 hours post-dose
Title
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)
Description
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)
Time Frame
up to 24 hours post-dose
Secondary Outcome Measure Information:
Title
Time to Maximum drug concentration in plasma (tmax)
Description
Time corresponding to maximum drug concentration in plasma measured in Hours(h)
Time Frame
up to 3 hours post-dose
Title
Elimination half life of drug in plasma ( t½)
Description
Elimination half life of drug measured in Hours(hr)
Time Frame
Up to 24 hours post-dose
Title
Area under the plasma concentration-time curve from time 0 to infinity
Description
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)
Time Frame
Up to 24 hours post-dose
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
subjects are to provide their national IDs to confirm that subjects are male subjects
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa A Sabri, phD
Organizational Affiliation
Ainshams university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed M Hussein, Msc student
Organizational Affiliation
Ainshams university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed A Raslan
Organizational Affiliation
Drug Research Centre, Cairo, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Drug Research Centre
City
Cairo
State/Province
Sheraton Heliopolis
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers
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