Cimetidine Biowaivers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Maryland
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
University of Maryland
ClinicalTrials.gov Identifier:
NCT01256879
First received: November 15, 2010
Last updated: November 21, 2013
Last verified: November 2013
  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.


Condition Intervention Phase
Healthy
Drug: cimetidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Excipient Effects on Biopharmaceuticals Classification System (BCS) Class 3 Drug Cimetidine

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • amount of drug in blood [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    Blood samples will be collected to measure level of cimetidine.


Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT01256879     History of Changes
Other Study ID Numbers: HP-00046139, HHSF2232000910020C
Study First Received: November 15, 2010
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
cimetidine
pharmacokinetics
formulation

Additional relevant MeSH terms:
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014