Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01514903
First received: January 18, 2012
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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 subjects.


Condition Intervention Phase
Erectile Dysfunction
Drug: HIP0908
Drug: viagra
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUC and Cmax of sildenafil [ Time Frame: before administration to 14 hours after administration ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: December 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: viagra,anti-drectile dysfunction agent Drug: viagra
single dose, cross over
Experimental: HIP0908 Drug: HIP0908
SINGLE DOSE , CROSS OVER

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc > 430ms or uncontrolled arrhythmia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514903

Locations
Korea, Republic of
Sinchon Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01514903     History of Changes
Other Study ID Numbers: HM-SIL-102
Study First Received: January 18, 2012
Last Updated: January 20, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Hanmi Pharmaceutical Company Limited:
anti erectile dysfunction agent

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological

ClinicalTrials.gov processed this record on October 29, 2014