A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers

Exclusion Criteria

• •1. Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYGK1 formulation
• •2. Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
• •3. Presence or history of severe gastrointestinal disease in the last 6 months
• •4. Presence or history of renal insufficiency at any time (serum creatinine \>UNL)
• •5. Active liver disease and/or liver transaminases greater than 1.5 X UNL
• •6. History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)
• •7. Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT)
• •8. History or presence of any medication in the last 14 days
• •9. History or presence of significant alcoholism or drug abuse within the past 1 year
• •10. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
• •11. Difficulty with donating blood
• •12. Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg
• •13. Pulse rate less than 60 minute and more than 100/minute
• •14. Any clinically significant laboratory findings during screening
• •15. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
• •16. Major illness and/or major surgery in last 3 months
• •17. Volunteers who have participated in any drug research study other than the present trial within past 3 months
• •18. Volunteers who have donated one unit (350 ml) of blood in the past 3 months