KCT0008397
已完成
未知
A Randomized, Open-Label, 3-Way Crossover Clinical Study to Compare and Evaluate the Pharmacokinetics and Safety of Vildagliptin SR and Galvus Tab. and Evaluate the Food Effect on the Pharmacokinetics of Vildagliptin SR in Healthy Adult Volunteers
Alvogen Korea0 个研究点目标入组 42 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Not Applicable
- 发起方
- Alvogen Korea
- 入组人数
- 42
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\) Those who have been provided with sufficient explanations on the objective and content of the study and characteristics of the investigational product, and voluntarily signed the informed consent form approved by the IRB to participate in the study
- •2\) Healthy adults aged 19 to 45 years at the time of screening
- •3\) Men who weigh 50kg or more and women who weigh 45kg or more, with a body mass index (BMI) of \=18\.0 and \= 30\.0
- •(BMI (kg/m2\) \= Weight (kg) / \[Height (m)]2\)
排除标准
- •1\) Those with clinically significant history such as hypersensitivity reaction, intolerance, or anaphylaxis to vildagliptin, the active pharmaceutical ingredient (API) of the investigational product, and other components
- •2\) Those with clinically significant history in liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, blood and tumor system, and cardiovascular system (including orthostatic hypotension)
- •3\) Those with history of gastrointestinal diseases (e.g., Crohn’s disease, ulcerative diseases, etc.) or surgery (except for appendectomy, herniotomy, endoscopic polyp surgery, hemorrhoids/ anal fissure/anal fistula surgery) that may affect the absorption of investigational products
- •4\) Drug abusers (particularly central nervous system drugs such as alcohol, sleeping pills, central nervous system analgesics, opiates or psychotropic drugs) or those with a history of drug abuse ? Alcohol abuse is defined as continuous consumption of over 21 units/week (alcohol 1 unit \= 10 g \= 12\.5 mL) within the last six months
- •5\) Those who showed positive results in HBsAg, HCV Ab, HIV Ab, or VDRL test at screening
- •6\) Those whose AST or ALT level exceeds 2 times the normal upper limit at screening
- •7\) Those with levels of systolic blood pressure \> 150 mmHg or \< 90 mmHg, or diastolic blood pressure \> 95 mmHg or \< 60 mmHg in vital signs at screening
- •8\) Those who are judged to have a clinically significant abnormal result in the screening tests (medical interview, vital signs, Electrocardiogram(ECG), physical examination, blood, urinalysis, etc.)
- •9\) Those who have participated in other clinical trials and received the investigational product within 6 months of the scheduled investigational product administration (except for the case of not taking the investigational product)
- •10\) Those who have taken any medicines (prescription medicines, over\-the\-counter medicines, herbal medicines or nutritional supplements (vitamins, etc.) within 2 weeks prior to screening
结局指标
主要结局
未指定
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