ALK29-002: A Study of Baclofen Formulations in Healthy Adults
NCT ID: NCT00802035
Last Updated: 2011-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2008-11-30
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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IR am
30 mg, single dose, morning administration (immediate release \[IR\])
Baclofen IR
30 mg; single dose
ER am
30 mg; single dose; morning administration (extended release \[ER\])
Baclofen ER
30 mg; single dose
ER pm
30 mg; single dose; evening administration
Baclofen ER
30 mg; single dose
IR pm
30 mg; single dose; evening administration
Baclofen IR
30 mg; single dose
Interventions
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Baclofen IR
30 mg; single dose
Baclofen ER
30 mg; single dose
Eligibility Criteria
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Inclusion Criteria
* Body mass index of 19 to 30 kg/m2 at screening
* If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study
Exclusion Criteria
* Clinical significant medical condition or observed abnormalities
* Acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery
* Participation in a clinical trial within 30 days before screening
* Known intolerance and/or hypersensitivity to baclofen or its excipients
* Use of alcohol-, caffeine-, or xanthine-containing products
* Clinically significant illness within 30 days of first study drug administration
* Dietary restrictions that conflict with required study meals
18 Years
65 Years
ALL
Yes
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frederick A. Bieberdorf, MD, CPI
Role: PRINCIPAL_INVESTIGATOR
CEDRA Clinical Research, LLC
Locations
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CEDRA Clinical Research, LLC
Austin, Texas, United States
Countries
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Other Identifiers
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ALK29-002
Identifier Type: -
Identifier Source: org_study_id
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