NCT02587975Unknown4 期
Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
研究概览
简要总结
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal healthy women (at least 5 years)
- •BMI 18~30 kg/m2
排除标准
- •Presence or history of hypersensitivity or allergic reactions to any drug
- •Clinically relevant abnormal medical history or present disease
- •Presence or history of drug abuse
- •Participation in other clinical trial within 2 months before dose.
- •Bood donation during 2 months or apheresis during 1 month before the study.
- •Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.
- •Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc.
- •Smoking of more than 10 cigarettes/days within 3 months before first dose.
- •Use of alcohol over 21 units/weeks
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
Evogliptin 10 mg
Experimental
Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL
干预措施: Evogliptin (Drug)
结局指标
主要结局
Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
时间窗: Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2
次要结局
未报告次要终点
研究者
Namyi Gu
Assistant professor
DongGuk University
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic DysfunctionLiver DysfunctionNCT02754219Dong-A ST Co., Ltd.24
尚未招募
不适用
The Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes MellitusDiabete Type 2Bone MetabolismNCT06182852Nanjing First Hospital, Nanjing Medical University330
已完成
1 期
The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis PatientsHemodialysis PatientsNCT04195919Dong-A ST Co., Ltd.17
已完成
不适用
Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.Multiple MyelomaNCT01026701Janssen Korea, Ltd., Korea104
已完成
2 期
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal WomenPostmenopausal OsteoporosisNCT01321723Unigene Laboratories Inc.97