ClinicalTrials.gov
ClinicalTrials.gov Menu

Cimetidine Biowaivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01256879
Recruitment Status : Unknown
Verified November 2013 by University of Maryland.
Recruitment status was:  Recruiting
First Posted : December 9, 2010
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of Maryland

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: cimetidine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Excipient Effects on Biopharmaceuticals Classification System (BCS) Class 3 Drug Cimetidine
Study Start Date : March 2011
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Cimetidine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: formulation 1
cimetidine capsule with hydroxypropyl methylcellulose (HPMC), a type of filler
Drug: cimetidine
cimetidine 200mg total dose (single dose) per arm
Experimental: formulation 2
cimetidine capsule with magnesium stearate, a type of filler
Drug: cimetidine
cimetidine 200mg total dose (single dose) per arm
Active Comparator: formulation 3
commercial cimetidine solution
Drug: cimetidine
cimetidine 200mg total dose (single dose) per arm
Experimental: formulation 4
experimental (non-commercial) cimetidine solution
Drug: cimetidine
cimetidine 200mg total dose (single dose) per arm



Primary Outcome Measures :
  1. amount of drug in blood [ Time Frame: 10 hours ]
    Blood samples will be collected to measure level of cimetidine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256879


Contacts
Contact: James Polli 410-706-8292 jpolli@rx.umaryland.edu

Locations
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: James Polli    410-706-8292    cimetidinedrugstudy@rx.umaryland.edu   
Principal Investigator: James Polli         
Sponsors and Collaborators
University of Maryland
Food and Drug Administration (FDA)
Investigators
Principal Investigator: James Polli, PhD University of Maryland

Publications:
Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT01256879     History of Changes
Other Study ID Numbers: HP-00046139
HHSF2232000910020C ( Other Grant/Funding Number: HHSF2232000910020C )
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by University of Maryland:
cimetidine
pharmacokinetics
formulation

Additional relevant MeSH terms:
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors