At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone When Administered Individually or Concurrently
In Brief
A Phase 1 clinical trial evaluating Baclofen 20 mg Tablet, Chlorzoxazone 500 mg Tablet, and 1 other intervention for Pharmacokinetics. Completed, enrolled 19 participants across 1 site.
Detailed Summary
Combination treatment with baclofen and chlorzoxazone (CHZ) is under investigation for the treatment of spinocerebellar ataxia types 1 and 2. Achievement of therapeutic benefit with this combination approach requires that effective concentrations of both agents reach the systemic circulation, and ultimately reach the intended pharmacologic target. This in turn requires understanding of the clinical pharmacokinetic properties of both drugs when administered individually, as well as knowledge of the extent to which the agents might interact when given concurrently. Study Objectives: 1. To evaluate the pharmacokinetic properties of baclofen and CHZ when administered as individual entities at separate times, using customary clinical doses. 2. To compare the pharmacokinetic properties, and assess the bioequivalence, of each drug administered separately compared to administration of the two drugs concurrently. 3. To assess adverse events attributed to the two drugs when administered separately or together.
Study Details
Timeline
Interventions
Single oral dose given at approximately 8 AM on day of visit, with 6-8 ounces of tap water.
Single oral dose given at approximately 8 AM on day of visit, with 6-8 ounces of tap water.
Concurrent single oral dose given at approximately 8 AM on day of visit, with 6-8 ounces of tap water.