Status:
COMPLETED
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
45+ years
Phase:
PHASE1
Brief Summary
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.
Eligibility Criteria
Inclusion
- Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.
- Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.
- Signed and dated informed consent document.
Exclusion
- Evidence or history of clinically significant abnormalities
- Have baseline orthostatic hypotension
- Positive drug screen, excessive alcohol and tobacco use
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01254383
Start Date
December 1 2010
End Date
March 1 2011
Last Update
February 1 2021
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770