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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
History of Changes
  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:

U.S. FDA Resources

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
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
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013