跳至主要内容
临床试验/NL-OMON44056
NL-OMON44056已完成不适用

OPEN-LABEL, RANDOMIZED STUDY TO ASSESS THE SAFETY AS WELL AS THE PHARMACOKINETIC PROFILE AND TO INVESTIGATE THE EFFICACY TRENDS ON BIOMARKERS IN TYPE 2 DIABETES MELLITUS PATIENTS OF A SUSTAINED RELEASE FORMULATION OF EXENATIDE BASED ON MEDUSA* TECHNOLOGY - Exenatide MPF SAD and MAD study

FLAMEL TECHNOLOGIES0 个研究点目标入组 64 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Gender: healthy male or female
  • Age: 18 - 65 years, inclusive
  • Body Mass Index: >22.0 - <35.0 kg/m2 ;Part B:
  • Gender: male or female T2DM patients
  • Age: 18 - 75 years, inclusive
  • Body Mass Index: >25.0 - <40.0 kg/m2

排除标准

  • Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

研究者

发起方
FLAMEL TECHNOLOGIES

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