- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00904748
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate (A1481272)
January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.
The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bio-equivalence between two formulations of sildenafil citrate
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Braganca Paulista, SP, Brazil, 12916-900
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Reference
|
sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
|
EXPERIMENTAL: Test 1
|
sildenafil citrate 100 mg CT, single dose without water
sildenafil citrate 100 mg CT, single dose with water
|
EXPERIMENTAL: Test 2
|
sildenafil citrate 100 mg CT, single dose without water
sildenafil citrate 100 mg CT, single dose with water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC 0-t)
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
|
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
|
Maximum Plasma Concentration (Cmax)
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve From 0 to Infinity (AUC 0-inf )
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
|
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
|
Time to Maximum Plasma Concentration (Tmax)
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
|
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
|
Half-life (T 1/2)
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
|
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
|
Number of Participants With Clinically Significant Findings in Vital Signs
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
May 19, 2009
First Submitted That Met QC Criteria
May 19, 2009
First Posted (ESTIMATE)
May 20, 2009
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Erectile Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Anticoagulants
- Phosphodiesterase Inhibitors
- Chelating Agents
- Sequestering Agents
- Phosphodiesterase 5 Inhibitors
- Calcium Chelating Agents
- Sildenafil Citrate
- Citric Acid
- Sodium Citrate
Other Study ID Numbers
- A1481272
- JPJ 39/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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