[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study evaluating Vorasidenib 40 mg tablets from two different manufacturers in healthy adult participants under fasting conditions.
主要研究目的:研究空腹状态下单次口服受试制剂Vorasidenib片(规格: 40 mg,施维雅(天津)制药有限公司 生产 )与参比制剂Vorasidenib片(VORANIGO®,规格 40 mg;Rottendorf Pharma GmbH生产 )在健康参与者体内的药代动力学特征,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂Vorasidenib片(规格:40 mg)和参比制剂(VORANIGO®)(规格:40 mg)在健康参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of the test formulation Vorasidenib tablets (40 mg, manufactured by Servier (Tianjin) Pharmaceutical Co., Ltd.) and the reference formulation Vorasidenib tablets (VORANIGO®, 40 mg; manufactured by Rottendorf Pharma GmbH) in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting oral administration.
Secondary objective: To investigate the safety of the test formulation Vorasidenib tablets (40 mg) and the reference formulation (VORANIGO®) (40 mg) in healthy participants.