Search

Weihong Li,1,* Yanrong Wang,1,* Yingzi Pei,2 Yue Xia2 1GCP Office of Cangzhou Central Hospital, Cangzhou, Hebei, 061000, People’s Republic of China; 2Research Center of Beijing Fuyuan Pharmaceutical Co., Ltd. (Formerly Beijing Wansheng Pharmaceutical Co., Ltd.), Beijing, 101113, People’s Republic of China*These authors contributed equally to this workCorrespondence: Weihong LiGCP Office of Cangzhou Central Hospital, No. 16 on Xinhua Road, Cangzhou, Hebei, 061000, People’s Republic of ChinaTel +86 18713731395Fax +86 3172072825Email sarry610@163.comPurpose: The aim of this study was to assess and compare the pharmacokinetic (PK) properties and bioequivalence of montelukast sodium chewable tablets prepared by two different manufacturers in healthy Chinese volunteers to obtain adequate PK evidence for the registration approval of the test formulation.Patients and Methods: A randomized-sequence, single-dose, open-label, 2-period crossover study was conducted in fasted and fed healthy Chinese volunteers (Chinese Clinical Trials Registry identifier: CTR20182362). Eighteen subjects each were selected for a fasted study and a fed study. Eligible participants were randomly assigned in a 1:1 ratio to receive a single dose of the reference formulation or the test formulation, followed by a 5-day washout period and the administration of the alternate formulation. Plasma samples were collected over a 24-hour period following tablet administration and analyzed for montelukast contents by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The PK parameters, such as maximum serum concentration (Cmax), area under the curve (AUC) from t = 0 to the last quantifiable concentration (AUC0–t), AUC from t = 0 to infinity (AUC0–∞), half-life (t1⁄ 2), time to Cmax (Tmax), and terminal elimination rate constant (λz), were evaluated. The safety assessment included changes in vital signs (