A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.

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Detailed Description

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Bio-equivalence between two formulations of sildenafil citrate

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test 1

Group Type EXPERIMENTAL

sildenafil citrate 100 mg CT

Intervention Type DRUG

sildenafil citrate 100 mg CT, single dose without water

Test 2

Group Type EXPERIMENTAL

sildenafil citrate 100 mg CT

Intervention Type DRUG

sildenafil citrate 100 mg CT, single dose with water

Reference

Group Type ACTIVE_COMPARATOR

Viagra®

Intervention Type DRUG

sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

Interventions

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sildenafil citrate 100 mg CT

sildenafil citrate 100 mg CT, single dose without water

Intervention Type DRUG

sildenafil citrate 100 mg CT

sildenafil citrate 100 mg CT, single dose with water

Intervention Type DRUG

Viagra®

sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index higher or equal to 18,5 and lower or equal than 29,9 kg/m2.
* Good health conditions or without significant disease, at medical discretion, according to the rules defined in the Protocol, and evaluations undergone: clinical history, pulse and blood pressure measurements, physical and psychological examination, ECG and complementary laboratory examination.
* Able to understand the study nature and objective, including the risks and adverse effects and willing to cooperate with the investigator and act according to all the trial requirements, which is confirmed by signing the Informed Consent Form.

Exclusion Criteria

* Hypersensitivity to the study drug or to the chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug.
* History or presence of hepatic or gastrointestinal diseases, or other condition that affects the drug absorption, distribution, excretion or metabolism
* History of hepatic, renal, lung, gastrointestinal, epileptic, hematological or psychiatric disease; hypo or hypertension of whatever etiology which demands treatment with drugs; history or occurrence of myocardial infarction, angina and/or cardiac failure;

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes