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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514903
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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 subjects.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: HIP0908 Drug: viagra Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: viagra,anti-erectile dysfunction agent Drug: viagra
single dose, cross over
Experimental: HIP0908 Drug: HIP0908

Primary Outcome Measures :
  1. 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 ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514903

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

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01514903     History of Changes
Other Study ID Numbers: HM-SIL-102
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 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