A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate (A1481272)

Viatris

Status and phase

Completed

Phase 1

Conditions

Erectile Dysfunction

Treatments

Drug: Viagra®

Drug: sildenafil citrate 100 mg CT

Study type

Interventional

Funder types

Industry

Identifiers

A1481272

JPJ 39/09

Details and patient eligibility

About

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

Full description

Bio-equivalence between two formulations of sildenafil citrate

Enrollment

47 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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;