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Lack of Pharmacokinetic Interaction between Tiagabine and Erythromycin

Departments of Clinical Pharmacology, Novo Nordisk A/S, Bagsvaerd, Denmark

Lisbet Groes, PhD

Statistics, Novo Nordisk A/S, Bagsvaerd, Denmark

Henrik Agerso, PhD

Pharmacokinetics, Novo Nordisk A/S, Bagsvaerd, Denmark

Trine Kruse, MSc

Clinical Reporting, Novo Nordisk A/S, Bagsvaerd, Denmark

This study was conducted to investigate the effects on the pharmacokinetics of tiagabine at steady state when coaministered with therapeutic doses of erythromycin. Tiagbine doses of 4 mg twice daily and erythromycin doses of 500 mg twice daily were administered for 4 days in an open-label, crossover, two-period interaction trial in 13 healthy volunteers. No statistically significant differences in maximum plasma concentration (CinaJ, area under the concentration-time curve (A UCJ), or half-life (t) of tiagbine were observed when tiagabine was administered alone or in combination with erythromycin. A statistically significant treatment effect was observed for time to maimum concentration (t₁₁₁ax; 0.72 after tiagabine alone vesus 0.56 hours after administration with erythromycin). No statistically significant differences were seen between men and women except in tmax and t,; these differences were thought to be of no clinical significance. The decrease in tl,,, seen in women in this study is interpreted as a diffeential effect of erythromycin on gastric emptying of fmales and not as an interaction between tiagabine and erythromycin. No changes in laboratory parameters or vtal signs were attributable to trial medication. The most common treatment-emergent adverse events that were posibly related to trial medication were central nervous sytem effects (e.g., headache, dizziness); all adverse events were transient, the majority were rated mild in severity, and did not require additional action. Coadministration of erythromycin in healthy subjects does not significantly affect the pharmacokinetics of tiagabine at the doses tested.

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