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Repeated Dose IV Baclofen Safety/Bioequivalence Study

NCT02760992 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-11-29

No results posted yet for this study

Summary

The purpose of this study is to identify a suitable dosing regimen of IV baclofen to serve as a temporary substitute for an oral regimen.

Conditions

  • Intravenous Baclofen

Interventions

DRUG

IV Baclofen

Baclofen intravenous solution 2 mg/mL manufactured and provided by Allaysis, LLC

DRUG

Oral Baclofen

10 mg tablet

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2017-09-30
Completion
2017-12-31

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Entities

Companies

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 NCT02760992 on ClinicalTrials.gov