Cimetidine Biowaivers
Information source: University of Maryland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: cimetidine (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Maryland Official(s) and/or principal investigator(s): James Polli, PhD, Principal Investigator, Affiliation: University of Maryland
Overall contact: James Polli, Phone: 410-706-8292, Email: jpolli@rx.umaryland.edu
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.
Clinical Details
Official title: Evaluation of Excipient Effects on Biopharmaceuticals Classification System (BCS) Class 3 Drug Cimetidine
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: amount of drug in blood
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 absorption and result in bioINequivalence. 2) Alternative hypothesis is that
commonly used excipients in oral medications do not change the rate or extent of Class 3
drug absorption and do not result in bioINequivalence.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
James Polli, Phone: 410-706-8292, Email: jpolli@rx.umaryland.edu
University of Maryland, Baltimore, Maryland 21201, United States; Recruiting James Polli, Phone: 410-706-8292, Email: cimetidinedrugstudy@rx.umaryland.edu James Polli, Principal Investigator
Additional Information
Related publications: Rege BD, Yu LX, Hussain AS, Polli JE. Effect of common excipients on Caco-2 transport of low-permeability drugs. J Pharm Sci. 2001 Nov;90(11):1776-86.
Starting date: March 2011
Last updated: November 21, 2013
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