Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man

Janet Dickerson, D. Perrier, M. Mayersohn, R. Bressler

Research output: Contribution to journalArticle

32 Scopus citations

Abstract

Dose tolerance and pharmacokinetic studies of pseudoephedrine sustained action capsules were performed in thirty-three adult male subjects who received either 120 mg or 150 mg capsules every twelve hours for seven consecutive days in a double-blind parallel design study. Although only one subject in the 150 mg group was discontinued prematurely from this study, a large number of side effects typical of CNS stimulation were seen. A placebo effect might account for a portion of these complaints, however symtoms evaluated as being due to drug were significantly more severe and persistent in the 150 mg group. Pulse rates showed a persistent and significant increase while systolic and diastolic blood pressure fell from the baseline values in both groups. A pharmacokinetic analysis of the pseudoephedrine plasma concentration-time data provided estimates of half-life and the volume of distribution/availability ratio. The values obtained were in good agreement with values reported by others. Half-life was not influenced by urine pH probably as a result of the narrow range of urine pHs observed in the subjects. Calculations of relative bioavailability suggest that the 120 mg capsule formulation has a 30% greater bioavailability compared to the 150 mg capsule.

Original languageEnglish (US)
Pages (from-to)253-259
Number of pages7
JournalEuropean Journal of Clinical Pharmacology
Volume14
Issue number4
DOIs
StatePublished - Jul 1 1978

Keywords

  • Pseudoephedrine
  • bioavailability
  • multiple oral dosing
  • side effects

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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