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Cimetidine Biowaivers

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ClinicalTrials.gov Identifier: NCT01256879
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
James E Polli, University of Maryland, Baltimore

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: Drug: cimetidine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 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
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines
Drug Information available for: Cimetidine

Arm Intervention/treatment
Experimental: CimTest-A
200mg cimetidine (as 2 capsules)
Drug: Drug: cimetidine
cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
Other Name: Tagamet

Experimental: CimTest-B
200mg cimetidine (as 2 capsules)
Drug: Drug: cimetidine
cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
Other Name: Tagamet

Active Comparator: Sorbitol-free cimetidine solution
200mg cimetidine (as oral liquid)
Drug: Drug: cimetidine
cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
Other Name: Tagamet

Experimental: Commercial cimetidine solution
200mg cimetidine (as oral liquid)
Drug: Drug: cimetidine
cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
Other Name: Tagamet




Primary Outcome Measures :
  1. AUC [ Time Frame: 0-10 hours ]
    pharmacokinetic exposure (ng*hr/ml)



Information from the National Library of Medicine

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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


Locations
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United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: James Polli, PhD University of Maryland, Baltimore
Publications:
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Responsible Party: James E Polli, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT01256879    
Other Study ID Numbers: HP-00046139
HHSF2232000910020C ( Other Grant/Funding Number: HHSF2232000910020C )
First Posted: December 9, 2010    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by James E Polli, University of Maryland, Baltimore:
cimetidine
pharmacokinetics
formulation
Additional relevant MeSH terms:
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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