Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale
Condition: Healthy
Intervention: Cholestyramine; Colesevelam HCl
Intervention description: Cholestyramine 12 grams, one time dose; Colesevelam HCl, 4 grams, one time dose
Intervention MeSH terms: Colesevelam Hydrochloride; 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; Lipids; Glucose; Cholesterol; Diabetes Mellitus; Bile Acid Sequestrant Acceptability Scale

Summary:

      The objective of this study is to compare the acceptability of Colesevelam HCl powder for
      oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated
      equivalent cholesterol lowering doses of each comparator drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18-70 years of age

          -  In general good health (defined as study participants who are medically stable, meet
             protocol criteria, but who may also have non-exclusionary ongoing medical conditions).

          -  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

          -  Known Phenylketonuria. Colesevelam (Welchol) for Oral Suspension contains 48 mg
             phenylalanine per 3.75 gram dose.

          -  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 gallbladder disease

          -  History of pancreatitis

          -  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

          -  Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within
             30 days 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.