Stereoselective versus non stereoselective assessments for the bioequivalence of two formulations of racemic chlorpheniramine
- Author:
Bui Tung Hiep
- Publication Type:Journal Article
- Keywords:
Chlorpheniramine
- MeSH:
Chlorpheniramine;
Therapeutic Equivalency
- From:Journal Ho Chi Minh Medical
2005;9(3):166-170
- CountryViet Nam
- Language:Vietnamese
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Abstract:
The bioequivalence of two formulations (reference and Vietnamese tested formulation) of racemic chlorpheniramine combined with phenylpropanolamine was assessed in an open-labeled, randomized, crossover two-period study in 12 healthy Vietnamese males aged between 22 and 43 years old, weight between 48kg and 72kg. All 12 subjects received both formulations after an overnight fast and a 7 day wash-out period. Plasma samples were collected up to 168 hours. Plasma concentrations of total chlorpheniramine and individual enantiomers were determined with a validated chiral HPLC method and pharmacokinetic parameters were estimated using a model independent analysis. Bioequivalence was assessed by several different published statistical methods (ANOVA, Confidence Interval, Westlake, and Schuirmann). Results showed that bioequivalence may depend on the statistical and analytical methods used
