[Translation] An open-label, randomized, single-dose, three-cycle, six-sequence, crossover, bioavailability study comparing MTS004 orally disintegrating tablets to NUEDEXTA® in healthy adult subjects in the fasting state
主要研究目的
本研究的主要目的是评估健康成人受试者在空腹条件下,单次给予MTS004口崩片(受试制剂)(直接无水吞服或用水送服)和氢溴酸右美沙芬硫酸奎尼丁胶囊(参比制剂,商品名:NUEDEXTA®)的药代动力学(PK)特征,并计算受试制剂在直接无水吞服和用水送服方式下与参比制剂相比氢溴酸右美沙芬(DM, 20 mg)和硫酸奎尼丁(Q, 10 mg)的相对生物利用度。
次要研究目的
本研究的次要目的是评估健康成人受试者在空腹条件下单次给予受试制剂后的安全性。
[Translation] Main research purpose
The primary objective of this study was to evaluate a single administration of MTS004 orally disintegrating tablets (test formulation) (to be swallowed directly or with water) and dextromethorphan hydrobromide quinil sulfate under fasting conditions in healthy adult subjects Pharmacokinetics (PK) characteristics of Ding Capsules (reference preparation, trade name: NUEDEXTA®), and the calculation of the test preparation in direct anhydrous swallowing and water administration compared with the reference preparation. Relative bioavailability of methorphan (DM, 20 mg) and quinidine sulfate (Q, 10 mg).
Secondary research purpose
A secondary objective of this study was to evaluate the safety of a single dose of the test formulation in healthy adult subjects under fasting conditions.