Document Detail


Bioequivalence assessment of a pregabalin capsule and oral solution in fasted healthy volunteers: a randomized, crossover study.
MedLine Citation:
PMID:  23357837     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To determine the oral bioavailability of a pregabalin capsule relative to a pregabalin solution.
METHODS: This was an open-label, randomized, crossover study in 12 healthy volunteers. Pharmacokinetics were compared for a 100-mg capsule and a 100-mg capsule dissolved in water, administered fasted.
RESULTS: Mean Cmax and AUC0-∞ for the capsule were within 2% of those for the solution (3.8 vs. 3.7 μg/ml and 26.7 vs. 27.0 μg×h/ml, respectively). The 90% confidence intervals for the ratios of Cmax and AUC0-∞ fell fully within 80 - 125%.
CONCLUSIONS: A 100-mg pregabalin capsule is bioequivalent to a pregabalin solution (100-mg capsule dissolved in water).
Authors:
Howard N Bockbrader; Christine W Alvey; Brian W Corrigan; Louis L Radulovic
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of clinical pharmacology and therapeutics     Volume:  51     ISSN:  0946-1965     ISO Abbreviation:  Int J Clin Pharmacol Ther     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-27     Completed Date:  2013-06-18     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  9423309     Medline TA:  Int J Clin Pharmacol Ther     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  244-8     Citation Subset:  IM    
Affiliation:
Parke Davis Pharmaceutical Research, Ann Arbor, MI, USA. howard.bockbrader@a2pg.com
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Analgesics / adverse effects,  pharmacokinetics*
Capsules
Cross-Over Studies
Fasting
Female
Humans
Male
Middle Aged
Therapeutic Equivalency
gamma-Aminobutyric Acid / adverse effects,  analogs & derivatives*,  pharmacokinetics
Chemical
Reg. No./Substance:
0/Analgesics; 0/Capsules; 55JG375S6M/pregabalin; 56-12-2/gamma-Aminobutyric Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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