A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study
Condition: Healthy
Intervention: Cholestyramine; Cholestyramine; Tang
Intervention description: Cholestyramine 4 grams one time dose; Cholestyramine 12 grams one dose, one day; Tang one dose one day
Intervention MeSH terms: Cholestyramine Resin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bile acid sequestrant; Resin; Cholesterol; Diabetes mellitus; Lipids; Glucose; Bile Acid Sequestrant Acceptability Scale (BASA)validation study

Summary:

      The purpose of the research study is (1) to rate the taste, texture, appearance, and
      mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored
      Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating
      cholestyramine and Tang to determine the accuracy and usefulness of a taste test
      questionnaire.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects or generally healthy volunteers are eligible for inclusion if they meet the
        following inclusion criteria during the Screening Period:

          -  Men or women 18-70 years of age

          -  In general good health.

          -  Subjects are capable of giving informed consent, or if appropriate, have an acceptable
             surrogate capable of giving consent on the subject's behalf.

          -  Subjects are willing and readily able to be contacted for post-study safety phone call
             assessments one to seven days after the single study visit.

        Exclusion Criteria:

          -  Prior intolerance to bile acid sequestrants

          -  Women who are either pregnant, or who are not practicing any form of birth control.

          -  Prior gastrointestinal surgery

          -  History of ongoing gastrointestinal symptoms (indigestion, constipation, or diarrhea)

          -  History of bowel obstruction, malabsorption, or irritable bowel syndrome

          -  History of esophageal disease

          -  Current or past history of gall bladder disease

          -  Subjects enrolled in another experimental (interventional) protocol within the past 30
             days prior to visit 1.

          -  Diagnosis of diabetes mellitus

          -  Known history of triglyceride levels > 300 mg/dl.

          -  History of alcohol or drug abuse within 1 year of study entry

          -  Alcohol intake that exceeds more than 2 units of alcohol drinks per day

          -  Blood donation within 8 weeks of the study or anticipation of blood donation during
             the study.

          -  Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within
             30 of visit 1).

          -  Any other situation in which the Investigator makes the judgment that participation in
             the study would not be in the best interest of the study participant, or in the best
             interest of providing reliable study data.