Trials / Completed
CompletedNCT02103686
Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- IlDong Pharmaceutical Co Ltd · Industry
- Sex
- Male
- Age
- 19 Years – 44 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to: 1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2). 2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lyrica | |
| DRUG | Experimental drug | sustained release formulation of pregabalin |
| DIETARY_SUPPLEMENT | High fat meal | |
| DIETARY_SUPPLEMENT | fasted |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2012-12-01
- Completion
- 2013-01-01
- First posted
- 2014-04-04
- Last updated
- 2014-09-01
Source: ClinicalTrials.gov record NCT02103686. Inclusion in this directory is not an endorsement.