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Appel-Dingemanse, S. et al.

Appel-Dingemanse, Horowitz, Campestrini, Osborne, McLeod,

The pharmacokinetics of the novel promotile drug, tegaserod, are similar in healthy subjects-male and female, elderly and young.

BACKGROUND: Tegaserod (HTF 919) is a selective 5-HT4 receptor partial agonist in development for the treatment of irritable bowel syndrome. AIM: This study aimed to assess the effect of age and gender on the single-dose pharmacokinetics of tegaserod. METHODS: In a parallel-group, open-label study, a single dose of tegaserod (12 mg) was administered to four groups of healthy young male, young female, elderly male and elderly female subjects (n=10 per group). Blood samples were collected from 0 to 24 h postdose. Non-compartmental pharmacokinetics evaluation and statistical analysis (ANOVA and Wilcoxon signed ranks test for tmax) were performed. RESULTS: Tegaserod was well tolerated in all groups. There was no effect of age or gender on tmax and Cmax. Gender did not affect AUC0-infinity and AUC0-tz; there was a statistically significant effect of age on these parameters. AUC0-infinity and AUC0-tz in the elderly were greater than in the young (AUC0-infinity ratio 1.37, P < 0.001; AUC0-tz ratio 1.23, P=0.029). This increase in exposure is judged not to be clinically relevant because it is within the variability in the pharmacokinetics parameters of tegaserod and because the dose-response relationship of tegaserod is relatively shallow. CONCLUSIONS: No dose adjustment for age or gender is recommended in tegaserod therapy.[1]

References

The pharmacokinetics of the novel promotile drug, tegaserod, are similar in healthy subjects-male and female, elderly and young. Appel-Dingemanse, S., Horowitz, A., Campestrini, J., Osborne, S., McLeod, J. Aliment. Pharmacol. Ther. (2001) [Pubmed]

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