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OpenTrials
Completed

NCT Number: NCT00902512

Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Col. Arenal Tepepan, Mexico City, 14610, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment A

Drug

Viagra® 100 mg tablet, administered with water single dose

Blood samples for the analysis of sildenafil in plasma

Drug

Blood samples for the analysis of sildenafil in plasma

Treatment B

Drug

Sildenafil 100 mg CT administered with water single dose

Blood samples for the analysis of sildenafil in plasma

Other

Blood samples for the analysis of sildenafil in plasma

Treatment C

Drug

Sildenafil 100 mg CT administered without water single dose

Primary outcomes

  1. AUC0-T and Cmax of sildenafil

    Time frame: 28 days

Secondary outcomes

  1. AUC0-inf of sildenafil

    Time frame: 28 days

  2. Tmax and half-life of sildenafil

    Time frame: 28 days

  3. Adverse events and vital signs

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 15, 2009
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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