Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects

Exclusion Criteria

• •1. History or presence of significant respiratory, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, or psychiatric disease.
• •2. Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal products (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections,acute inflammations, etc.).
• •3. Presence of liver impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT) above the normal reference range.
• •4. Presence of significant kidney impairment: serum creatinine higher than the normal reference range.
• •5. Allergy to band aids, adhesive dressing or medical tape.
• •6. Clinically significant history or presence of ECG abnormalities such as second- or third-degree atrioventricular block; evidence, or family history, of prolonged QT syndrome.
• •7. Sustained sitting systolic blood pressure of \<90 mmHg or \>140 mmHg, or diastolic blood pressure of \>95 mmHg at screening or check-in of Period 1.
• •8. History or presence of hypersensitivity or idiosyncratic reaction to deferiprone, moxifloxacin, iron chelators, or quinolone antibiotics.
• •9. History or presence of:
• •* agranulocytosis;
• •* asthma;
• •* chronic bronchitis;
• •* diabetes;
• •* migraine;
• •* hypertension;
• •* hypotension;
• •* hypokalemia;
• •* seizures or epilepsy;
• •* anaemia.
• •10. History or presence of alcoholism or drug abuse within the past 2 years.
• •11. Used tobacco/nicotine-containing product for at least 3 months prior to the first dose of study.
• •12. Used Depo-Provera® or levonorgestrel implant within 90 days prior to the first dose and throughout the study.
• •13. Participation in another clinical trial within 28 days prior to the first dose of the study.
• •14. Had a clinically significant illness during the 4 weeks prior to check-in on Day -1 of Period 1.