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Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00902512
Collaborator
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V. (Other)
30
Enrollment
1
Location
3
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Treatment A
  • Drug: Blood samples for the analysis of sildenafil in plasma
  • Drug: Treatment B
  • Other: Blood samples for the analysis of sildenafil in plasma
  • Drug: Treatment C
  • Other: Blood samples for the analysis of sildenafil in plasma
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

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

Drug: Treatment C
Sildenafil 100 mg CT administered without water single dose

Other: Blood samples for the analysis of sildenafil in plasma
Blood samples for the analysis of sildenafil in plasma

Outcome Measures

Primary Outcome Measures

  1. AUC0-T and Cmax of sildenafil [28 days]

Secondary Outcome Measures

  1. AUC0-inf of sildenafil [28 days]

  2. Tmax and half-life of sildenafil [28 days]

  3. Adverse events and vital signs [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Col. Arenal Tepepan Mexico D.F. Mexico 14610

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
  • Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00902512
Other Study ID Numbers:
  • A1481267
First Posted:
May 15, 2009
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Additional relevant MeSH terms:
Sildenafil Citrate

Study Results

No Results Posted as of Feb 1, 2021