Cimetidine Biowaivers
Condition: Healthy
Intervention: Drug: cimetidine
Intervention description: cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
Intervention MeSH terms: Cimetidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cimetidine; pharmacokinetics; formulation

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.
    

Eligibility 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.