Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg

Exclusion Criteria

• •1. Females who are pregnant or are lactating
• •2. Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study (from the screening visit until study completion)
• •3. History of significant hypersensitivity to cetirizine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• •4. Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
• •5. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
• •6. Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• •7. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
• •8. Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 200 msec, QRS \< 60 msec, QRS \>110 msec and QTc \> 440 msec) on the screening ECG or other clinically significant ECG abnormalities
• •9. Known presence of rare hereditary problems of galactose and /or lactose intolerance
• •10. Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• •11. Any clinically significant illness in the previous 28 days before day 1 of this study
• •12. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before day 1 of this study
• •13. Use of antihistaminic medication in the previous 7 days before day 1 of this study
• •14. Any history of tuberculosis and/or prophylaxis for tuberculosis
• •15. Positive urine screening of ethanol and/or drugs of abuse
• •16. Positive results to HIV, HBsAg or anti-HCV tests
• •17. Females who are pregnant according to a positive serum pregnancy test
• •18. Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
• •19. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study