A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

Phase 1

Completed

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

Detailed Description: Bio-equivalence between two formulations of sildenafil citrate

Recruitment & Eligibility

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;

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose	Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
Area Under the Curve (AUC 0-t)	Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose	Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms\hour/milliliter (ng\hr/mL).

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Plasma Concentration (Tmax)	Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose	Time at which maximum plasma concentration (Cmax) occurred.
Half-life (T 1/2)	Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose	Terminal elimination half-life.
Number of Participants With Clinically Significant Findings in Vital Signs	Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.	Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.
Area Under the Curve From 0 to Infinity (AUC 0-inf )	Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose	Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms \hour/milliliter (ng\hr/mL).