Kaza Michał, Leś Andrzej, Serafin-Byczak Krystyna, Ksycińska Hanna, Rudzki Piotr J, Gutkowskpi Piotr, Drewniak Tomasz, Gutkowska Anna, Tarasiuk Andrzej, Piatkowska-Chabuda Ewa, Skowrońska-Smolak Małgorzata, Wilkowska Ewa
Pharmaceutical Research Institute, Pharmacology Department, Warszawa, Poland.
Acta Pol Pharm. 2012 Nov-Dec;69(6):1356-63.
The aim of the study was to investigate the bioavailability of a generic product of 500 mg cefuroxime axetil film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both products. A double blinded, randomized, crossover, two-period, single-dose, comparative study was conducted in Caucasian healthy volunteers in fasting conditions. A single oral dose administration of the test or reference product was followed by 7-day wash-out period. The cefuroxime concentration was determined using a validated HPLC-UV method. The results of the single-dose study in healthy volunteers indicated that the film-coated tablets of Tarsime 500 mg manufactured by Tarchomińskie Zakłady Farmaceutyczne Polfa S.A. (test product) are bioequivalent to those of Zinnat manufactured by GlaxoSmithKline Export Ltd. (reference product). Both products were well tolerated.
本研究的目的是调查500毫克头孢呋辛酯薄膜包衣片仿制药（试验品）与相同规格的品牌药（参比品）的生物利用度，以确定生物等效性并申请监管批准。本研究的次要目的是评估两种产品的耐受性。在禁食条件下，对高加索健康志愿者进行了一项双盲、随机、交叉、两期、单剂量的对照研究。单次口服试验品或参比品后，有7天的洗脱期。使用经过验证的高效液相色谱 - 紫外法测定头孢呋辛的浓度。健康志愿者单剂量研究的结果表明，由塔尔乔明斯克制药厂波尔法股份公司（试验产品）生产的500毫克塔尔西姆薄膜包衣片与葛兰素史克出口有限公司生产的新菌灵（参比产品）生物等效。两种产品耐受性良好。
