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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
sildenafil citrate 100 mg CT
sildenafil citrate 100 mg CT
Viagra®
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Erectile Dysfunction focused on measuring Sildenafil, Bio-equivalence

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts 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;

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Test 1

Test 2

Reference

Arm Description

Outcomes

Primary Outcome Measures

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).
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).

Secondary Outcome Measures

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).
Time to Maximum Plasma Concentration (Tmax)
Time at which maximum plasma concentration (Cmax) occurred.
Half-life (T 1/2)
Terminal elimination half-life.
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.

Full Information

First Posted
May 19, 2009
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00904748
Brief Title
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Sildenafil, Bio-equivalence

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test 1
Arm Type
Experimental
Arm Title
Test 2
Arm Type
Experimental
Arm Title
Reference
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate 100 mg CT
Intervention Description
sildenafil citrate 100 mg CT, single dose without water
Intervention Type
Drug
Intervention Name(s)
sildenafil citrate 100 mg CT
Intervention Description
sildenafil citrate 100 mg CT, single dose with water
Intervention Type
Drug
Intervention Name(s)
Viagra®
Intervention Description
sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC 0-t)
Description
Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).
Time Frame
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
Title
Maximum Plasma Concentration (Cmax)
Description
Maximum plasma concentration measured in nanograms per milliliter (ng/mL).
Time Frame
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 Outcome Measure Information:
Title
Area Under the Curve From 0 to Infinity (AUC 0-inf )
Description
Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).
Time Frame
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
Title
Time to Maximum Plasma Concentration (Tmax)
Description
Time at which maximum plasma concentration (Cmax) occurred.
Time Frame
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
Title
Half-life (T 1/2)
Description
Terminal elimination half-life.
Time Frame
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
Title
Number of Participants With Clinically Significant Findings in Vital Signs
Description
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.
Time Frame
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Braganca Paulista
State/Province
SP
ZIP/Postal Code
12916-900
Country
Brazil

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481272&StudyName=A%20Relative%20Bioavailability%20Study%20Between%20Two%20Formulations%20Of%20Sildenafil%20Citrate
Description
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A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate

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