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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04100759
Other study ID # SIL-RES-0119
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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