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- Title
A Pilot Study Assessing Pharmacokinetics and Tolerability of Oral and Intravenous Baclofen in Healthy Adult Volunteers.
- Authors
Agarwal, Suresh K.; Kriel, Robert L.; Cloyd, James C.; Coles, Lisa D.; Scherkenbach, Lisa A.; Tobin, Michael H.; Krach, Linda E.
- Abstract
Our objective was to characterize baclofen pharmacokinetics and safety given orally and intravenously. Twelve healthy subjects were enrolled in a randomized, open-label, crossover study and received single doses of baclofen: 3 or 5 mg given intravenously and 5 or 10 mg taken orally with a 48-hour washout. Blood samples for baclofen analysis were collected pre-dose and at regular intervals up to 24 hours post-dose. Clinical response was assessed by sedation scores, ataxia, and nystagmus. Mean absolute bioavailability of oral baclofen was 74%. Dose-adjusted areas under the curve between the oral and intravenous arms were statistically different (P = .0024), whereas area under the curve variability was similar (coefficient of variation: 18%-24%). Adverse effects were mild in severity and not related to either dose or route of administration. Three- and 5-mg intravenous doses of baclofen were well tolerated. Seventy-four percent oral bioavailability indicates that smaller doses of intravenous baclofen are needed to attain comparable total drug exposures.
- Subjects
DRUG metabolism; PILOT projects; EYE movement disorders; NYSTAGMUS; CARDIOVASCULAR system
- Publication
Journal of Child Neurology, 2015, Vol 30, Issue 1, p37
- ISSN
0883-0738
- Publication type
Article
- DOI
10.1177/0883073814535504