EUCTR2014-004993-40-Outside-EU/EEA进行中（未招募）不适用
A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents - A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males or females who are 10 - 17 years of age
- •History of type 2 diabetes
- •No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes
- •See protocol for complete list of inclusion criteria.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of diabetic ketoacidosis
- •History of stroke, chronic seizures or major neurological disorder
- •Consumes alcohol
- •Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other beverages containing caffeine per day
- •Unable to swallow tablets
- •Has had surgery, donated or lost 1 unit of blood, or participated in another investigational study within a minimum of 4 weeks prior to starting the study
- •History of multiple and/or severe allergies or has had an allergic reaction to or significant intolerability to prescription or non-prescription drugs or food
- •Currently a regular user of any illicit drugs or has a history of drug or alcohol abuse
- •History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •Has an estimated creatinine clearance of less than or equal to 80 mL/min
- •Refer to protocol for complete list.
研究者
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