Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.

NCT00795938

Erectile Dysfunction

COMPLETED PHASE1

A Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects

NCT00866463

Erectile Dysfunction

COMPLETED PHASE1

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

NCT00904748

Erectile Dysfunction

COMPLETED PHASE1

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

NCT01254383

Erectile Dysfunction

COMPLETED PHASE1

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

NCT01254396

Erectile Dysfunction

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Males

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A

Viagra® 100 mg tablet, administered with water

Group Type ACTIVE_COMPARATOR

Treatment A

Intervention Type DRUG

Viagra® 100 mg tablet, administered with water single dose

Blood samples for the analysis of sildenafil in plasma

Intervention Type DRUG

Blood samples for the analysis of sildenafil in plasma

Treatment B

Sildenafil 100 mg CT administered with water

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Sildenafil 100 mg CT administered with water single dose

Blood samples for the analysis of sildenafil in plasma

Intervention Type OTHER

Blood samples for the analysis of sildenafil in plasma

Treatment C

Sildenafil 100 mg CT administered without water

Group Type ACTIVE_COMPARATOR

Treatment C

Intervention Type DRUG

Sildenafil 100 mg CT administered without water single dose

Blood samples for the analysis of sildenafil in plasma

Intervention Type OTHER

Blood samples for the analysis of sildenafil in plasma

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treatment A

Viagra® 100 mg tablet, administered with water single dose

Intervention Type DRUG

Blood samples for the analysis of sildenafil in plasma

Intervention Type DRUG

Treatment B

Sildenafil 100 mg CT administered with water single dose

Intervention Type DRUG

Blood samples for the analysis of sildenafil in plasma

Intervention Type OTHER

Treatment C

Sildenafil 100 mg CT administered without water single dose

Intervention Type DRUG

Blood samples for the analysis of sildenafil in plasma

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Only healthy male volunteers in the 18-40 age range will be included.
* At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90
* The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication
* History of hypersensitivity to sildenafil citrate or any components of its formulations

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes