Pharmacodynamics and Pharmacokinetics of 3 New Developed Coated Glucose Beads in 20 Obese Healthy Subjects

Exclusion Criteria

• •Gastrointestinal, hepatic and renal diseases and/or pathological findings which might interfere with pharmacokinetics and pharmacodynamics of the investigational product
• •Established diagnosis of type-1 or type-2 diabetes mellitus
• •Treatment with insulin, insulin secretagogues (sulfonylurea derivatives, glinides, GLP-1 agonists (exenatide, lixisenatide, glutides), or thiazolidinediones (glitazones)
• •Unexplained rise in blood glucose
• •Treatment for constipation (including but not limited to lactulose or any other form of stool softeners, laxatives) or diarrhea (including but not limited to pectins. loperamide etc.) or any other medication known to interfere with gastrointestinal transit time, such as e.g., metoclopramide, opioids, or gastric Potential of Hydrogen (pH) (including but not limited to antacids, H2-receptor antagonists, prazole)
• •Tea, coffee or other caffeine containing beverage drinkers (more than 0.4 L per day)
• •History of hypersensitivity to the investigational product or any related drugs or to any of the excipients
• •History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, hematological, gastrointestinal, endocrinologic, immunologic, dermatologic. neurological, psychiatric, metabolic, musculoskeletal, or malignant disease, which the clinical investigator does not consider a disqualification for participation in the study
• •Known heart failure (Grade I to IV of New York Heart Association classification)
• •Significant renal disease. including nephritic syndrome chronic renal failure (defined as creatinine clearance\< 60 mL/min and serum creatinine \>180 μmol/L)
• •Unexplained serum creatine phosphokinase (CPK) \> 3-times the upper limit of normal (ULN) Subjects with a reason for CPK elevation may have the measurement repeated prior to randomization a CPK retest\> 3-times ULN leads to exclusion
• •Clinically significant illness or surgery within 4 weeks prior to dosing
• •Less than 14 days after last acute disease
• •Volunteers liable to orthostatic dysregulation, fainting, or blackouts
• •Donation or loss of blood equal to or exceeding 500 ml during 90 days before the first administration of investigational product
• •Participation in another study with an experimental drug within at least 3 months (or within five elimination half-lives of the previous experimental drug, whichever is longer) before the first administration of investigational product
• •Any use of drug, prescribed or over-the-counter (OTC) (inclusive herbal remedies), within 2 weeks (or within six elimination half-lives of this medication, whichever is longer) prior to the first administration of investigational product except if this will not affect the outcome of the study in the opinion of the clinical investigator
• •Unwillingness or inability to comply with the study protocol or study-related procedures (e.g., difficulty to stay fasting, consume the standard meals, or swallow the beads formulations; difficult venous access).