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

September 22, 2019 updated by: Mohamed Raslan, Ain Shams University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sheraton Heliopolis
      • Cairo, Sheraton Heliopolis, Egypt
        • Drug Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Non-Smokers
Subjects administer one tablet of sildenafil 50 mg
Drug: Sildenafil 50 mg Oral Tablet
Sildenafil 50 mg Oral Tablet
Other Names:
  • Viagra 50 mg film coated tablets
Experimental: Cigarette Smokers
Subjects administer one tablet of sildenafil 50mg
Drug: Sildenafil 50 mg Oral Tablet
Sildenafil 50 mg Oral Tablet
Other Names:
  • Viagra 50 mg film coated tablets
Experimental: Cannabis Smokers
Subjects administer one tablet of sildenafil 50mg
Drug: Sildenafil 50 mg Oral Tablet
Sildenafil 50 mg Oral Tablet
Other Names:
  • Viagra 50 mg film coated tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum drug concentration in plasma (Cmax)
Time Frame: up to 3 hours post-dose
Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)
up to 3 hours post-dose
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)
Time Frame: up to 24 hours post-dose
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Maximum drug concentration in plasma (tmax)
Time Frame: up to 3 hours post-dose
Time corresponding to maximum drug concentration in plasma measured in Hours(h)
up to 3 hours post-dose
Elimination half life of drug in plasma ( t½)
Time Frame: Up to 24 hours post-dose
Elimination half life of drug measured in Hours(hr)
Up to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity
Time Frame: Up to 24 hours post-dose
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Drug Research Centre, Cairo, Egypt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nagwa A Sabri, phD, AinShams university
  • Principal Investigator: Mohammed M Hussein, Msc student, AinShams university
  • Study Director: Mohamed A Raslan, Drug Research Centre, Cairo, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIL-RES-0119

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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