Erectile Dysfunction Clinical Trial
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Sinchon Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanmi Pharmaceutical Company Limited |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC and Cmax of sildenafil | 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 | Yes |
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