Back to resultsPharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HIP0908
viagra
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring anti erectile dysfunction agent
Eligibility 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
Sites / Locations
- Sinchon Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
viagra,anti-erectile dysfunction agent
HIP0908
Arm Description
Outcomes
Primary Outcome Measures
AUC and Cmax of sildenafil
Secondary Outcome Measures
Full Information
NCT ID
NCT01514903
First Posted
January 18, 2012
Last Updated
October 11, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01514903
Brief Title
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
anti erectile dysfunction agent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
viagra,anti-erectile dysfunction agent
Arm Type
Active Comparator
Arm Title
HIP0908
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HIP0908
Intervention Description
SINGLE DOSE , CROSS OVER
Intervention Type
Drug
Intervention Name(s)
viagra
Intervention Description
single dose, cross over
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Sinchon Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
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