Status:
COMPLETED
Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Tufts University
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 a...
Detailed Description
Baclofen has been available for clinical use in the United States since 1977 and is used for the treatment of spasticity arising from a variety of causes. Oral baclofen can be administered in tablet f...
Eligibility Criteria
Inclusion
- Healthy male or female
- Ages 18 to 55 years of age
- Ambulatory
- Non-smoker
- No current or past history of significant medical or psychiatric disease
- Not currently taking prescription medications or on a regular or recurrent basis
Exclusion
- Non-ambulatory
- Smokers
- Current or past history of significant medical or psychiatric disease
- Currently taking prescription medications or taking on a regular or recurrent basis
- Available information about potential participant indicates that participation would not be safe or appropriate, per PI discretion
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05257447
Start Date
April 27 2022
End Date
December 13 2022
Last Update
March 31 2023
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390