KCT0008397已完成Unknown
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 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
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
- •11) Those who donated whole blood within 8 weeks prior to screening or who donated blood components (plasma, platelets) within 4 weeks or who did not agree to ban blood donation from the time of investigational product administration to 30 days after the last administration
- •12) Those who smoke over 10 cigarettes per day within 6 months prior to screening
- •13) Those who are unable to use clinically acceptable contraceptives (e.g., infertility surgery of the subject and his or her partner, intrauterine contraceptives, combination with diaphragm or condom, etc.) from the time of investigational product administration to the last visit
- •14) Those who cannot prohibit diet (especially, grapefruit juice or caffeine) that may affect the absorption, distribution, metabolism and excretion of the drug from 3 days before the first investigational product administration to the last pharmacokinetic (PK) sampling.
- •15) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •16) Women who showed a positive result on Urine-hCG test
- •17) In addition to the above, those who are deemed unsuitable by the investigator for participation in this clinical study
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