Status:
COMPLETED
Cimetidine Biowaivers
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 c...
Detailed Description
The investigators anticipate that common excipients do not cause bioINequivalence. 1) The hypothesize is that commonly used excipients in oral medications change the rate or extent of Class 3 drug abs...
Eligibility Criteria
Inclusion
- Male or Female
- Age 18-55
- Healthy volunteers: Subjects in good health, as determined by screening evaluation that is not greater than 30 days before the first drug study visit
- Willing to avoid caffeine containing products 24 hours prior to and day of study visits
- Willing to stop all over the counter medications for 24 hours prior to and during study visits
- Able to provide informed consent
Exclusion
- Presence of significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric)
- Presence of hepatic, renal disease
- Pregnant women, breast feeding or trying to become pregnant
- Excessive alcohol use (i.e. current physical, behavioral, or personal manifestations related to the abuse or dependency on alcohol)
- Routine use (i.e. daily or weekly) prescription medication except birth control pills
- Routine use (i.e. daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate gastrointestinal function
- Currently taking cimetidine or medication known to interact with cimetidine
- Allergic to cimetidine
- Undergoing therapy for solid tumor or blood malignancy
- Any condition in which in the opinion of the PI or medical physician would increase risk to the subject or interfere with the integrity of the study.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01256879
Start Date
March 1 2011
End Date
May 1 2014
Last Update
August 28 2019
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201