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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Page 1 of 1 (1 locations)

1

Sinchon Severance Hospital

Seoul, South Korea