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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.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited Identifier:
First received: January 18, 2012
Last updated: October 11, 2016
Last verified: October 2016
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
Intervention Model: Crossover Assignment
Masking: None (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: Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose ]

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-erectile dysfunction agent Drug: viagra
single dose, cross over
Experimental: HIP0908 Drug: HIP0908


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01514903

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

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01514903     History of Changes
Other Study ID Numbers: HM-SIL-102
Study First Received: January 18, 2012
Last Updated: October 11, 2016

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
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on August 18, 2017