Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05257447 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT05257447 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 19 participants.
The verdict
NCT05257447, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
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.
Interventions
- DRUG Baclofen 20 mg Tablet
- DRUG Chlorzoxazone 500 mg Tablet
- DRUG Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2022-12-13 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05257447
The ClinicalTrials.gov registry entry for NCT05257447 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Baclofen 20 mg Tablet is the first listed.
NCT05257447 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05257447 about?
NCT05257447 is a clinical study titled "Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently". 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 ul...
What is the current status of trial NCT05257447?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2022-04-27. Estimated completion is 2022-12-13.
What interventions are being tested in trial NCT05257447?
The interventions under investigation include: Baclofen 20 mg Tablet (DRUG), Chlorzoxazone 500 mg Tablet (DRUG), Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet (DRUG).
Who is sponsoring clinical trial NCT05257447?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.