[Translation] A multicenter, randomized, double-blind, placebo-controlled phase Ib clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of Duanjin Detoxification Capsule in patients recovering from opioid addiction
主要目的:评价断金戒毒胶囊在阿片类物质成瘾康复期患者中的安全性、耐受性。
次要目的:评价断金戒毒胶囊在阿片类物质成瘾康复期患者中的药代动力学(PK)特征;初步评价断金戒毒胶囊在阿片类物质成瘾康复期患者中防复吸的有效性。
[Translation] Primary objective: To evaluate the safety and tolerability of Duanjin Detoxification Capsules in patients recovering from opioid addiction.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of Duanjin Detoxification Capsules in patients recovering from opioid addiction; to preliminarily evaluate the effectiveness of Duanjin Detoxification Capsules in preventing relapse in patients recovering from opioid addiction.