NCT00000320已完成1 期
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- blood level
研究概览
简要总结
The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
详细描述
- Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •M/F ages 18-
- •Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
排除标准
- •Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
研究组 & 干预措施
2; tablet formulation
Active Comparator
tablet formulation
干预措施: Buprenorphine formulation: liquid vs. tablet (Drug)
1; liquid formulation
Active Comparator
liquid formulation
干预措施: Buprenorphine formulation: liquid vs. tablet (Drug)
结局指标
主要结局
blood level
时间窗: across study duration
次要结局
- craving(across study duration)
- withdrawal symptoms(across study duration)
- drug use(across study duration)
研究者
研究点 (1)
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