Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine

National Institute on Drug Abuse (NIDA)2 个研究点分布在 1 个国家目标入组 1 人开始时间: 1996年8月最近更新: 2017年1月12日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: National Institute on Drug Abuse (NIDA)
入组人数: 1
试验地点: 2
主要终点: Subjective and observer rater physiological effects of bup

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 21 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•M/F ages 21-
•Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent.

排除标准

•Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

结局指标

主要结局

Subjective and observer rater physiological effects of bup

次要结局

未报告次要终点

研究者

发起方

National Institute on Drug Abuse (NIDA)

申办方类型

Nih

研究点 (2)

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Pharmacokinetic study to assess the bioavailability of the cocoa flavanols catechin and epicatechin from different matrices.Cocoa and chocolate products have generated significant interest due to their association with various health-protective and therapeutic activities. Cocoa and chocolate are rich sources of flavan-3-ols, which are present in monomeric and polymeric forms.

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