A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions

Roxane Laboratories1 个研究点分布在 1 个国家目标入组 18 人开始时间: 2006年8月1日最近更新: 2018年1月23日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Roxane Laboratories
入组人数: 18
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 designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg 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.

结局指标

主要结局

bioequivalence determined by statistical comparison Cmax

时间窗: 21 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

研究点 (1)

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