临床试验/NCT00931476

NCT00931476已完成1 期

A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)

Novo Nordisk A/S2 个研究点分布在 1 个国家目标入组 86 人开始时间: 2000年4月6日最近更新: 2017年2月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 86
试验地点: 2
主要终点: Area under the hGH concentration-time curve (GH AUC0-24h)

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

This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.

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: 20 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Signed informed consent before any trial related activities
•Japanese and Caucasian males respectively
•Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis
•Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive

排除标准

未提供

结局指标

主要结局

Area under the hGH concentration-time curve (GH AUC0-24h)

时间窗: from 0 to 24 hours following injection

Treatment Emergent Adverse Events

时间窗: from 0 to 24 hours following injection

Maximum hGH concentration (GH Cmax)

时间窗: from 0 to 24 hours following injection

次要结局

Area under the hGH concentration-time curve GH AUC0-∞)
Elimination half-life (GH t½)
Non-treatment Emergent Adverse Events
Time to maximum hGH concentration (GH tmax)
Growth Factors (IGF-I and IGFBP-3)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (2)

Loading locations...

相似试验

终止

1 期

First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical EffectsInflammationPsoriasis

NCT01261767Novo Nordisk A/S55

已完成

2 期

A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With MetforminDiabetes Mellitus Type 2Diabetes

NCT02205528Novo Nordisk A/S108

撤回

1 期

An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)InflammationSystemic Lupus Erythematosus

NCT01018238Novo Nordisk A/S

终止

1 期

A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy VolunteersMetabolism and Nutrition DisorderObesity

NCT01044108Novo Nordisk A/S117

已完成

1 期

A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 YearsMetabolism and Nutrition DisorderObesity

NCT02696148Novo Nordisk A/S24