NCT01122108

Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale

A Randomized, Single-Blind, Single Research Site, Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale in Generally Healthy Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Louisville Metabolic and Atherosclerosis Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

In 2009, colesevelam HCl was approved as a powder formulation. Little objective evidence exists comparing the acceptability of colesevelam HCl powder for oral suspension formulation versus other bile acid sequestrant powder formulations. A Bile Acid Sequestrant Acceptability (BASA) Scale was developed and validated as an instrument to compare the acceptability of different bile acid sequestrant preparations

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cholestyramine	Cholestyramine 12 grams, one time dose
DRUG	Colesevelam HCl	Colesevelam HCl, 4 grams, one time dose

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-05-13
• Last updated: 2010-10-07
• Results posted: 2010-10-07

Locations

1 site across 1 country: United States