临床试验/NCT01619345

NCT01619345已完成1 期

Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects

Novo Nordisk A/S0 个研究点目标入组 27 人开始时间: 2012年6月最近更新: 2015年2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: Novo Nordisk A/S
入组人数: 27
主要终点: Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)

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记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.

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 64 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Good general health
•Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)

排除标准

•Males who are not willing to use two acceptable forms of highly effective contraception
•Participation in another clinical trial within 90 days
•Any chronic disorder or severe disease
•Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing
•Subjects who are smokers
•Subjects who have donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

研究组 & 干预措施

Period 1: NN9924 with 50 mL water

Experimental

干预措施: semaglutide (Drug)

Period 2: NN9924 with 240 mL water

Experimental

干预措施: semaglutide (Drug)

结局指标

主要结局

Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)

时间窗: Assessed 0-4 hours post dose

次要结局

Area under the NN9924 concentration curve(From time 0-24 hours)
Anatomical location of initial tablet erosion (ITE)(Assessed 0-4 hours post dose)
Time to ITE(Assessed 0-4 hours post dose)
Time to CTE(Assessed 0-4 hours post dose)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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