Exploring the PK of Different Doses of Naltrexone in Patients With AUD

Summary

Study Design This study is related to a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of different doses of naltrexone implants in the treatment of patients with alcohol use disorders (protocol No.: SK2007-NQT-201, hereinafter referred to as II). This study plans to include 60 patients who are interested in participating in this study in Phase II patients, collect PK blood samples from patients, and conduct PK characteristic analysis. The collected plasma samples will be temporarily stored in a -80 ℃ refrigerator and tested after unblinding in Phase II.

Timeline

Start

2023-06-16

Primary completion

2023-12-31

Completion

2024-05-01

Drugs

Indications

No indication recorded.