临床试验/NCT01010152

NCT01010152已完成1 期

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting Conditions

Roxane Laboratories1 个研究点分布在 1 个国家目标入组 34 人开始时间: 2008年1月最近更新: 2018年1月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Roxane Laboratories
入组人数: 34
试验地点: 1
主要终点: bioequivalence determined by statistical comparison Cmax

研究概览研究设计入排标准研究组 & 干预措施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 objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions

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: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

排除标准

•Positive test for HIV, Hepatitis B, or Hepatitis C.
•Treatment with known enzyme altering drugs.
•History of allergic or adverse response to codeine sulfate or any comparable or similar product.

研究组 & 干预措施

Tylenol #3

Active Comparator

30 mg tablet

干预措施: Codeine Sulfate (Drug)

Codeine Sulfate

Experimental

30 mg tablet

干预措施: Codeine Sulfate (Drug)

结局指标

主要结局

bioequivalence determined by statistical comparison Cmax

时间窗: 15 days

次要结局

未报告次要终点

研究者

发起方

Roxane Laboratories

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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