A Study of Prasugrel in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/15/2012 |
| Start Date: | July 2012 |
| End Date: | August 2012 |
| Contact: | This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Phone: | 1-317-615-4559 |
Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects
The purpose of this study is to evaluate the amount of drug available in the body when given
to healthy participants as two different formulations with or without a meal. In addition,
this study will evaluate how much of the drug gets into the blood stream and how long the
body takes to get rid of it. Information about any side effects that may occur will also be
collected. Each participant will receive a total of five different treatments. Each
treatment is given by mouth, once a day. The treatment period lasts for five consecutive
days.
The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and
the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).
Inclusion Criteria:
- Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)
Exclusion Criteria:
- No known allergies to Prasugrel or related compound
- No regular alcohol intake greater than 21 units per week for males or 14 units per
week for females
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