[Translation] An open-label, randomized, single-dose, three-period, six-sequence, crossover, bioavailability study comparing MTS004 orodisintegrating tablets with NUEDEXTA® in healthy adult subjects under 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 study objectives
The main objective of this study is to evaluate the pharmacokinetic (PK) characteristics of MTS004 orodisintegrating tablets (test formulation) (swallowed directly without water or with water) and dextromethorphan hydrobromide and quinidine sulfate capsules (reference formulation, trade name: NUEDEXTA®) in healthy adult subjects under fasting conditions, and to calculate the relative bioavailability of dextromethorphan hydrobromide (DM, 20 mg) and quinidine sulfate (Q, 10 mg) of the test formulation compared with the reference formulation when swallowed directly without water or with water.
Secondary study objectives
The secondary objective of this study is to evaluate the safety of the test formulation after a single dose in healthy adult subjects under fasting conditions.