Overview

Cimetidine Biowaivers

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
Phase:
Phase 4
Details
Lead Sponsor:
University of Maryland
University of Maryland, Baltimore
Collaborator:
Food and Drug Administration (FDA)
Treatments:
Cimetidine