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ALK29-002: A Study of Baclofen Formulations in Healthy Adults

NCT00802035 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-08-23

No results posted yet for this study

Summary

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

Conditions

  • Alcohol Dependence

Interventions

DRUG

Baclofen IR

30 mg; single dose

DRUG

Baclofen ER

30 mg; single dose

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Frederick A. Bieberdorf, MD, CPI · CEDRA Clinical Research, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-12-31
Completion
2009-02-28

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 NCT00802035 on ClinicalTrials.gov