[Translation] A randomized, double-blind, placebo-controlled, dose-escalating Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and food effects of a single dose of NH160030 tablets in patients with non-cancer chronic pain
主要目的:评价非癌性慢性疼痛患者空腹单次口服不同给药剂量NH160030片的安全性和耐受性。
次要目的:评价非癌性慢性疼痛患者空腹单次口服不同给药剂量NH160030片的药物代谢动力学(PK)特性;鉴定NH160030片的体内代谢产物并检测其丰度。评价食物对NH160030片单次给药后药代动力学的影响。
探索性目的:如数据足够且可行,初步探索评价非癌性慢性疼痛患者空腹单次口服不同给药剂量NH160030片药效动力学(PD)特征,初步探索剂量-暴露-效应之间的关系。以上研究不作为临床报告的必要内容。
[Translation] Primary objective: To evaluate the safety and tolerability of NH160030 tablets of different doses taken orally on an empty stomach in patients with non-cancer chronic pain.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of NH160030 tablets of different doses taken orally on an empty stomach in patients with non-cancer chronic pain; to identify the in vivo metabolites of NH160030 tablets and detect their abundance. To evaluate the effect of food on the pharmacokinetics of NH160030 tablets after a single dose.
Exploratory objective: If the data is sufficient and feasible, preliminarily explore and evaluate the pharmacodynamic (PD) characteristics of NH160030 tablets of different doses taken orally on an empty stomach in patients with non-cancer chronic pain, and preliminarily explore the relationship between dose-exposure-effect. The above studies are not necessary for clinical reports.