Status:
COMPLETED
A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
Drug Research Centre, Cairo, Egypt
Conditions:
Erectile Dysfunction
Smoking
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 ...
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) inc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04100759
Start Date
June 11 2019
End Date
July 8 2019
Last Update
September 24 2019
Active Locations (1)
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1
Drug Research Centre
Cairo, Sheraton Heliopolis, Egypt