[Translation] A single-center, open, randomized, two-period, two-sequence, crossover pharmacokinetic comparative study to evaluate the pharmacokinetic efficacy of the experimental drug N2103 enteric-coated capsules (10 mg) and the control drug (5 mg) in healthy adult participants under fasting conditions.
主要试验目的:初步研究健康参与者在空腹状态下口服试验药N2103肠溶胶囊(规格:10mg)与对照药(规格:5mg)的药代动力学特征,为后期的开发策略提供参考。
次要试验目的:初步研究试验药N2103肠溶胶囊(规格:10mg)和对照药(规格:5mg)在健康参与者中的安全性。
[Translation] Main purpose of the trial: To preliminarily study the pharmacokinetic characteristics of the test drug N2103 enteric-coated capsules (specification: 10 mg) and the control drug (specification: 5 mg) when taken orally in the fasting state in healthy participants, so as to provide a reference for the later development strategy.
Secondary purpose of the trial: To preliminarily study the safety of the test drug N2103 enteric-coated capsules (specification: 10 mg) and the control drug (specification: 5 mg) in healthy participants.