Dose Tolerance and Pharmacokinetic Studies of L (+) Pseudoephedrine Capsules in Man
Document Type
Article
Publication Date
7-1-1978
Description
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.
Citation Information
Dickerson, Janet; Perrier, D.; Mayersohn, M.; and Bressler, R.. 1978. Dose Tolerance and Pharmacokinetic Studies of L (+) Pseudoephedrine Capsules in Man. European Journal of Clinical Pharmacology. Vol.14(4). 253-259. https://doi.org/10.1007/BF00560458 PMID: 729619 ISSN: 0031-6970