Food and Insulin Effect on QT/QTC Interval of ECG

Exclusion Criteria

• •1. History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
• •2. History of clinically significant syncope.
• •3. Family history of sudden death.
• •4. Family history of premature cardiovascular death.
• •5. Family history of congenital long QT syndrome or Brugada's syndrome.
• •6. History of arrhythmias and ischemic heart disease
• •7. Conditions predisposing to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
• •8. Abnormal ECG in the standard 12-lead ECG and 24-hour 12 lead Holter ECG
• •9. Abnormal rhythm, conduction or morphology of resting ECG, such as:
• •* Sinus node dysfunction.
• •* Clinically significant PR (PQ) interval prolongation.
• •* Intermittent second or third degree AV block.
• •* Incomplete or complete bundle branch block.
• •* Abnormal T wave morphology.
• •* Prolonged QTcB \>450 msec or shortened QTcB \< 350 msec or family history of long QT syndrome.
• •10. Abnormal blood glucose result (blood glucose \>7.8mmol/l)
• •11. Significant family history of diabetes mellitus.
• •12. Significantly elevated fasting blood glucose level
• •13. Signs and/or symptoms of acute illness in the four-week period prior to screening.
• •14. Veins unsuitable for intravenous puncture or cannulation on either arm
• •15. Known hypersensitivity to any medicines administered in the trial.
• •16. Treatment with any prescribed medication during the 2 weeks prior to first baseline day.
• •17. Treatment with any over-the-counter (OTC) medications during the 2 weeks prior to first baseline day.
• •18. Treatment with vitamins and/or minerals within 48 hours prior to the first baseline day.
• •19. Treatment with another investigational drug within 4 weeks prior to dosing or having participated in more than 3 investigational drug studies within a year prior to dosing.
• •20. Positive urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or the alcohol breath test
• •21. History or clinical evidence of alcoholism (regular weekly alcohol intake of more than 14 units if female and 21 units if male) or drug abuse (compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms)
• •22. Excessive caffeine consumption (≥800 mg per day)
• •23. Smoking within 3 months prior to screening
• •24. Loss of 250 mL or more blood within 3 months prior to screening.
• •25. Positive results from the hepatitis serology, except for vaccinated subjects.
• •26. Positive results from the HIV serology.
• •27. Any circumstances or conditions, which may affect full participation in the study or compliance with the protocol.
• •28. Legal incapacity or limited legal capacity.