Expired Study
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Baltimore, Maryland 21201


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

HP-00046139


NCT ID:

NCT01256879


Secondary ID:

HHSF2232000910020C


Study Acronym:


Brief Title:

Cimetidine Biowaivers


Official Title:

Evaluation of Excipient Effects on Biopharmaceuticals Classification System (BCS) Class 3 Drug Cimetidine


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Maryland, Baltimore


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:James Polli, PhD
Principal Investigator
University of Maryland, Baltimore

Study Dates

Start Date:March 2011
Completion Date:May 2014
Completion Type:Actual
Primary Completion Date:April 2014
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 13, 2019
First Received Date:November 15, 2010
First Results Date:March 17, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:AUC
Time Frame:0-10 hours
Safety Issues:False
Description:pharmacokinetic exposure (ng*hr/ml)

Study Interventions

Intervention Type:Drug
Name:Drug: cimetidine
Description:cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
Arm Name:CimTest-A
Other Name:Tagamet

Study Arms

Study Arm Type:Experimental
Arm Name:CimTest-A
Description:200mg cimetidine (as 2 capsules)
Study Arm Type:Experimental
Arm Name:CimTest-B
Description:200mg cimetidine (as 2 capsules)
Study Arm Type:Active Comparator
Arm Name:Sorbitol-free cimetidine solution
Description:200mg cimetidine (as oral liquid)
Study Arm Type:Experimental
Arm Name:Commercial cimetidine solution
Description:200mg cimetidine (as oral liquid)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Maryland, Baltimore
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Food and Drug Administration (FDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:11745735

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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