A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

Erectile Dysfunction Clinical Trial

— A1481272  

Official title:

A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate In Healthy Male Subjects, Fasting Dosing, Being The Test Formulation Sildenafil Citrate 100 Mg CT , And The Reference Formulation Sildenafil Citrate 100 Mg Film-Coated Tablets (Viagra®), Both Formulations Manufactured By Laboratórios Pfizer Ltda.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904748
• Other study ID #: A1481272
• Secondary ID: JPJ 39/09
• Status: Completed
• Phase: Phase 1
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Bio-equivalence between two formulations of sildenafil citrate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

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;

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• sildenafil citrate 100 mg CT
sildenafil citrate 100 mg CT, single dose without water
• sildenafil citrate 100 mg CT
sildenafil citrate 100 mg CT, single dose with water
• Viagra®
sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Braganca Paulista	SP

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC 0-t)	Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).	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
Primary	Maximum Plasma Concentration (Cmax)	Maximum plasma concentration measured in nanograms per milliliter (ng/mL).	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
Secondary	Area Under the Curve From 0 to Infinity (AUC 0-inf )	Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).	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
Secondary	Time to Maximum Plasma Concentration (Tmax)	Time at which maximum plasma concentration (Cmax) occurred.	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
Secondary	Half-life (T 1/2)	Terminal elimination half-life.	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
Secondary	Number of Participants With Clinically Significant Findings in Vital Signs	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.	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.

External Links

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