临床试验/NCT04631874

NCT04631874已完成1 期

A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline Tartrate)" in Healthy Male Volunteers

CTC Bio, Inc.1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2019年7月24日最近更新: 2020年11月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: CTC Bio, Inc.
入组人数: 32
试验地点: 1
主要终点: Pharmacokinetics (AUC0-t)

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

A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers

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: 19 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male subjects aged 19 to 45 years
•a body mass index of 18.0-30.0 kg/m2

排除标准

•Subjects with disease history or current disease of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, urinary system, cardiovascular system, etc.
•Subjects with a history of gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of investigational drugs
•Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing varenicline and other drugs (ketoprofen, aspirin, antibiotics, etc.)
•Subjects who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug, or who eat food that may affect drug metabolism

研究组 & 干预措施

Sequence A(RT)

Experimental

Reference drug (Champix) -> washout -> test drug (CDFF0318)

干预措施: CDFF0318, Champix (Drug)

Sequence B(TR)

Experimental

Test drug (CDFF0318) -> washout -> reference drug (Champix)

干预措施: CDFF0318, Champix (Drug)

结局指标

主要结局

Pharmacokinetics (AUC0-t)

时间窗: 72 hours

AUC0-t of "CDFF0318" and "Champix Tab. 1mg"

Pharmacokinetics (Cmax)

时间窗: 72 hours

Cmax of "CDFF0318" and "Champix Tab. 1mg"

次要结局

Safety and tolerability (Adverse events)(72 hours)
Safety and tolerability (Vital sign)(72 hours)
Safety and tolerability (Laboratory tests)(72 hours)
Safety and tolerability (12-lead ECG)(72 hours)

研究者

发起方

CTC Bio, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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