Status:
COMPLETED
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Erectile Dysfunction
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male sub...
Eligibility Criteria
Inclusion
- age between 20 and 45
- weight : over 55kg and 18.5 \< BMI, 25.0
- have to give their consent to participating clinical trial by oneself
Exclusion
- has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc \> 430ms or uncontrolled arrhythmia
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01514903
Start Date
December 1 2011
End Date
December 1 2011
Last Update
October 12 2016
Active Locations (1)
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1
Sinchon Severance Hospital
Seoul, South Korea