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Bioequivalency of generic and brand‐named chlorpromazine
Author(s) -
Simpson George M.,
Varga Ervin,
Reiss Martin,
Cooper Thomas B.,
Bergner Per-Erik E.,
Lee J. Hillary
Publication year - 1974
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1974156631
Subject(s) - chlorpromazine , crossover study , medicine , anesthesia , pharmacology , metabolite , placebo , alternative medicine , pathology
Fifty chronic schizophrenic patients were included in a double‐blind, crossover clinical and metabolite comparison of generic and Thorazine brand forms of chlorpromazine. Improvement was similar in quality and degree with the two compounds; there was no difference in frequency or severity of side effects or in incidence of laboratory abnormalities. Side effects consisted mainly of extrapyramidal reactions, drowsiness, and hypotension; the most serious were grand mal seizures that occurred in 2 patients, one on each compound. Weight changes and neuroleptic threshold were similar. Kinetic studies were carried out during the drug‐free intervals. Chlorpromazine, chlorpromazine nor 1 + 2 , and chlorpromazine sulfoxide nor 1 + 2 were measured over a 24 hour period. The characteristics of the mean curves were similar, although there were marked interindividual differences. The urinary recovery over the same period also demonstrated wide individual variability although the results from the same patients were similar. Because of the consistent similarites between generic and brand‐named chlorpromazine on the wide range of dimensions evaluated, we concluded that the two compounds were bioequivalent. The results suggest that the methodology used by us for examining bioequivalency is practicable and adequate.