Abstract

Comparative study of pharmacokinetics and bioequivalence of preparations containing nitisinone: Nitisinone, capsules 10 mg (ZAO Obninsk Chemical-Pharmaceutical Company (ZAO OCPC), Russia) and Orfadin®, capsules 10 mg (“Apotek Production and Laboratory AB”, Sweden) with a single capsule taken on an empty stomach by healthy volunteers. An open randomized cross-examination included 36 healthy volunteers. As a novel strategy the drugs (the test and the comparison drug) were administered once, followed by blood sampling for 72 hours. The “washout” period between study periods was 14 days. Nitisinone concentration in blood plasma samples was quantitatively determined by high-performance liquid chromatography with tandem mass spectrometry (HPLC/MS). The boundaries of the estimated 90% confidence intervals for the ratios of the mean values of the analyzed parameters (Cmax, AUC0-72) are within 80-125% according to the existing guidelines. Nitisinone is bioequivalent to Orfadin. Comparable drugs were also comparable in safety indicators.

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