临床试验/NCT00941239

NCT00941239已完成1 期

Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin

Laboratorios Silanes S.A. de C.V.1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2007年1月最近更新: 2018年1月30日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Laboratorios Silanes S.A. de C.V.
入组人数: 24
试验地点: 1
主要终点: Plasmatic drug concentration

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 purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)

排除标准

•Familiar or personal history of diabetes
•History of drug or alcohol abuse within the 2 years prior to the study
•A smoking habit greater than 10 cigarettes per day
•History of allergy to the study drugs
•Intercurrent disease
•Intercurrent treatment with any drug

研究组 & 干预措施

metformin ER

Experimental

Extended Release Metformin

干预措施: metformin ER (Drug)

metformin

Active Comparator

Immediate release metformin

干预措施: metformin (Drug)

结局指标

主要结局

Plasmatic drug concentration

时间窗: 48 hours (7.5, 15,30,45,60,75,90,120,150,180,205,240,360,480,600,720,1440,2880 min and days : 3,5,7,14,21,28,30,35)

次要结局

Lanza score(30 days (0 and 30))
plasmatic glucose(30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35))
Glycated hemoglobin(30 days (days: 0, 14 and 30))

研究者

发起方

Laboratorios Silanes S.A. de C.V.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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