[Translation] A Phase I clinical study to evaluate the safety, pharmacokinetics, food effects, single-dose dose proportionality of BM2216 extended-release tablets and multiple-dose pharmacokinetics comparison with melogabalin besylate tablets in healthy adult subjects - single-center, randomized, open, parallel/crossover
主要目的:
1)评价在空腹和餐后状态下健康成年受试者在单次口服BM2216缓释片后的药代动力学特征及食物影响;评价单次给药剂量比例关系。
2)评价BM2216缓释片与苯磺酸美洛加巴林片的单次和多次药代动力学特征对比及相对生物利用度。
次要目的:
评价健康成年受试者在单次和多次口服BM2216缓释片后的安全性。
[Translation] Main objectives:
1) To evaluate the pharmacokinetic characteristics and food effects of a single oral dose of BM2216 sustained-release tablets in healthy adult subjects in the fasting and fed state; to evaluate the proportional relationship of a single dose.
2) To evaluate the single and multiple pharmacokinetic characteristics and relative bioavailability of BM2216 sustained-release tablets and melogabalin besylate tablets.
Secondary objectives:
To evaluate the safety of BM2216 sustained-release tablets in healthy adult subjects after single and multiple oral doses.