Phase
Condition
Diabetes Mellitus, Type 2
Treatment
N/AClinical Study ID
Ages 19-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
[Inclusion Criteria]
Between 19 aged and 50 aged healthy adult
Body weight more than 55kg for male, more than 50kg for female
Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
if female, the subject must satisfy more than one of the following:
subject who have reached menopause (no natural menstruation for at least 2 years.)
subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)
[Exclusion Criteria]
Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
Subject with one of the following laboratory test results
AST, ALT > UNLx1.5
eGRF < 60 ml/min/1.73 m2 (MDRD formula)
immuno-serology test results in positive
Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg
- Subject who has history of the following and the history may affect safety of the subject or result of this study
History of any prescription drug or herbal medicine within 14 days before first administration investigational products
History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
History of drug-metabolizing induction/inhibition enzyme such as barbital
Study Design
Study Description
Connect with a study center
Severance Hospital
Seoul, Seodaemun-gu, 03722
Korea, Republic ofSite Not Available

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