Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.

the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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

  • Mexico
    • Mexico D.F.
      • Col. Arenal Tepepan, Mexico D.F., Mexico, 14610
        • 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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Only healthy male volunteers in the 18-40 age range will be included.
  • At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90
  • The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication
  • History of hypersensitivity to sildenafil citrate or any components of its formulations

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: Treatment A
Viagra® 100 mg tablet, administered with water
Drug: Treatment A
Viagra® 100 mg tablet, administered with water single dose
Drug: Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma
ACTIVE_COMPARATOR: Treatment B
Sildenafil 100 mg CT administered with water
Drug: Treatment B
Sildenafil 100 mg CT administered with water single dose
Other: Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma
ACTIVE_COMPARATOR: Treatment C
Sildenafil 100 mg CT administered without water
Other: Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma
Drug: Treatment C
Sildenafil 100 mg CT administered without water single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC0-T and Cmax of sildenafil
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC0-inf of sildenafil
Time Frame: 28 days
28 days
Tmax and half-life of sildenafil
Time Frame: 28 days
28 days
Adverse events and vital signs
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.

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.

Helpful Links

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

April 1, 2009

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (ESTIMATE)

May 15, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481267

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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