Summary
To evaluate the absorption and tolerability of a new formulation of pivampicillin administered as a 700 mg tablet, 14 healthy volunteers received single doses of 350, 500 and 700 mg p.o. Maximum serum concentrations (Cmax) of 5.73, 7.05 and 8.61 mg/l were obtained. The corresponding values for the area under the concentration/time curve (AUC) were 12.32, 18.99 and 25.30 mg/lxh. Concomitant intake of food increased the Cmax of the 700 mg tablet to 9.5 mg/l, while the AUC remained unchanged. Co-administration of the 700 mg pivampicillin dose with an antacid reduced the Cmax to 7.45 mg/l and the AUC to 17.92 mg/l × h. The tolerance of the 700 mg tablet was evaluated in a double-blind placebo-controlled study involving 57 patients. Six percent of the patients in each treatment group reported minor adverse reactions.
Zusammenfassung
Zur Beurteilung einer neuen Formulierung von Pivampicillin als 700 mg Tablette erhielten 14 gesunde freiwillige Probanden Einzeldosen der Substanz von 350, 500 und 700 mg per os. Die entsprechenden Spitzenspiegel (Cmax) lagen bei 5,73, 7,05 und 8,61 mg/l und die Fläche unter der Konzentrations-Zeitkurve (AUC) bei 12,32, 18,99 und 25,30 mg/l × h. Bei Einnahme der Tablette mit dem Essen erhöhte sich Cmax für die 700 mg Tablette auf 9,5 mg/l bei unveränderter AUC. Wenn Pivampicillin zusammen mit einem Antazidum eingenommen wurde, nahmen Cmax auf 7,45 mg/l und die AUC auf 17,92 mg/l × h ab. In einer placebokontrollierten Doppelblindstudie mit 57 Patienten wurde die Verträglichkeit der 700 mg Tablette geprüft. In jeder Gruppe berichteten 6% der Patienten über leichte Nebenwirkungen.
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Munkholm, P., Olsen, J., Hovgaard, J. et al. Absorption of pivampicillin as related to dose, and tolerability of a 700 mg tablet. Infection 21, 30–33 (1993). https://doi.org/10.1007/BF01739307
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DOI: https://doi.org/10.1007/BF01739307