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 language | English (US) |
|---|---|
| Pages (from-to) | 253-259 |
| Number of pages | 7 |
| Journal | European Journal of Clinical Pharmacology |
| Volume | 14 |
| Issue number | 4 |
| DOIs | |
| State | Published - Jul 1978 |
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Keywords
- bioavailability
- multiple oral dosing
- Pseudoephedrine
- side effects
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology (medical)
Cite this
Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man. / Dickerson, Janet; Perrier, D.; Mayersohn, Michael; Bressler, R.
In: European Journal of Clinical Pharmacology, Vol. 14, No. 4, 07.1978, p. 253-259.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man
AU - Dickerson, Janet
AU - Perrier, D.
AU - Mayersohn, Michael
AU - Bressler, R.
PY - 1978/7
Y1 - 1978/7
N2 - 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.
AB - 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.
KW - bioavailability
KW - multiple oral dosing
KW - Pseudoephedrine
KW - side effects
UR - http://www.scopus.com/inward/record.url?scp=0018241207&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0018241207&partnerID=8YFLogxK
U2 - 10.1007/BF00560458
DO - 10.1007/BF00560458
M3 - Article
VL - 14
SP - 253
EP - 259
JO - European Journal of Clinical Pharmacology
JF - European Journal of Clinical Pharmacology
SN - 0031-6970
IS - 4
ER -