NCT01256879

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

November 15, 2010

Results QC Date

March 17, 2015

Last Update Submit

August 13, 2019

Conditions

Healthy

Keywords

cimetidinepharmacokineticsformulation

Outcome Measures

Primary Outcomes (1)

  • AUC

    pharmacokinetic exposure (ng\*hr/ml)

    0-10 hours

Study Arms (4)

CimTest-A

EXPERIMENTAL

200mg cimetidine (as 2 capsules)

Drug: Drug: cimetidine

CimTest-B

EXPERIMENTAL

200mg cimetidine (as 2 capsules)

Drug: Drug: cimetidine

Sorbitol-free cimetidine solution

ACTIVE COMPARATOR

200mg cimetidine (as oral liquid)

Drug: Drug: cimetidine

Commercial cimetidine solution

EXPERIMENTAL

200mg cimetidine (as oral liquid)

Drug: Drug: cimetidine

Interventions

Drug: cimetidineDRUG

cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution

Also known as: Tagamet
CimTest-ACimTest-BCommercial cimetidine solutionSorbitol-free cimetidine solution

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • 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. doi: 10.1002/jps.1127.

    PMID: 11745735BACKGROUND

MeSH Terms

Interventions

Cimetidine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
James Polli, Professor
Organization
U of Maryland
jpolli@rx.umaryland.edu
410-706-8292

Study Officials

  • James Polli, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2010

First Posted

December 9, 2010

Study Start

March 1, 2011

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2019-08

Locations

US(1)