Registration Dossier
Registration Dossier
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EC number: 206-292-8 | CAS number: 321-97-1
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Dose tolerance and pharmacokinetic studies of pseudoephedrine capsules were performed in thirty-three adult male subjects who received either 120 mg or 150 mg every twelve hours for seven consecutive days in a double-blind parallel design study. One subject (in the 150 mg treatment group) was discontinued from the study prematurely due to primarily excitatory-type effects which increased in number, duration and severity.Both groups showed a similar significant and persistent increase in baseline blood pressure values. A large number of side effects which are typical symptoms of central nervous system stimulation were reported by both treatment groups including insomnia, anxiety, tachycardia, anorexia, and dryness of mouth. A placebo effect might account for a portion of these complaints, however a significant decline was seen in the mean number of reports of side effects during the 72 to 168 h time period in the lower dose group compared to the 0 to 60 h time period, while in the high dose group no decline was observed. Mean half-time was 5.9 h and 6.8 h, and mean steady state concentration was 447 and 510 ng/mL for the 120 mg and 150 mg group, respectively. The mean apparent volume of distribution was 2.64 and 3.51 for the 120 mg and 150 mg group respectively. Calculations of relative bioavailability suggest that the 120 mg capsule formulation has a 30% greater bioavailability compared to the 150 mg capsule.
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