Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
In order to meet FDA standards of safety and efficacy reporting for most new drugs,
food-effect bioavailability (the impact that the presence of food in the digestive tract has
on the rate and extent at which a drug is absorbed into the bloodstream and delivered to the
site of action) must be collected. Cystagon™ is an FDA approved drug for the treatment of the
rare disease cystinosis that became available in 1994, but there is inadequate knowledge of
the food-effect on this drug's bioavailability. This study aims to investigate how food
affects the absorption of Cystagon™ into the bloodstream of normal healthy adults.