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

NCT05919017 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-26

No results posted yet for this study

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.

Conditions

  • AUD

Interventions

DRUG

Naltrexone implant

Naltrexone implant

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shenzhen Sciencare Medical Industries Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • zou xuhui, Dr · Hunan Second People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2023-12-31
Completion
2024-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919017 on ClinicalTrials.gov