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Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently

NCT05257447 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-03-31

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Baclofen 20 mg Tablet

Single oral dose given at approximately 8 AM on day of visit, with 6-8 ounces of tap water.

DRUG

Chlorzoxazone 500 mg Tablet

Single oral dose given at approximately 8 AM on day of visit, with 6-8 ounces of tap water.

DRUG

Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet

Concurrent single oral dose given at approximately 8 AM on day of visit, with 6-8 ounces of tap water.

Sponsors & Collaborators

  • Tufts University

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Vikram Shakkottai, MD, PhD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2022-12-13
Completion
2022-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257447 on ClinicalTrials.gov