Trials / Completed
CompletedNCT00443625
Phase 1 Study of SK3530 to Investigate of the Effect of Food
Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (planned)
- Sponsor
- SK Chemicals Co., Ltd. · Industry
- Sex
- Male
- Age
- 19 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).
Detailed description
The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already accomplished and the results have provided useful information to the patients. The objective of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SK3530 |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2007-02-01
- Completion
- 2007-02-01
- First posted
- 2007-03-06
- Last updated
- 2013-04-18
Source: ClinicalTrials.gov record NCT00443625. Inclusion in this directory is not an endorsement.