Studio aperto per la valutazione dell efficacia dell insulina spray buccale sul controllo glicometabolico in soggetti con ridotta tolleranza ai carboidrati (studio PREVORAL 2). - PREVORAL 2

IVERSITA` CAMPUS BIOMEDICO0 个研究点开始时间: 2009年10月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Normal fasting glucose and post-prandial glucose levels between 140 to 199 mg/dL;
•2.Be male or female between the ages 18 to 80 years;
•3.Availability for the entire study period and willingness to adhere to protocol requirements as evidenced by a signed, written, informed consent;
•4.Current physical examination, vital signs or ECG at screening that reveals no clinically significant abnormalities;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•. Known history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, kidney disease, or conditions known to interfere with the absorption, distribution, metabolism or excretion of insulin;
•2. Any clinically significant illness during the four (4) weeks prior to entry into this study;
•3. Have a history of drug or alcohol abuse or psychological disease that in the opinion of the Investigator would interfere with participation in the protocol;
•4. Use of enzyme inducing and enzyme inhibiting drugs such as phenobarbital, and carbamazepine within 30 days prior to entry into this study;
•5. Have positive pregnancy test, or is a breast feeding woman , or a woman not using an adequate method of contraception;
•6. Have a history of diabetes;
•7. Have any acute illness within the 2 weeks prior to screening;
•8. Have elevated liver enzymes ALT, AST, gamma-glutamyl transpeptidase or alkaline phosphatase 3 times the upper limit of normal;
•9. Have received any investigational drug within 30 days prior to screening requiring blood donation.

发起方

IVERSITA` CAMPUS BIOMEDICO