Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers

Exclusion Criteria

• •1. Recent history of drug or alcohol addiction or abuse within the past year.
• •2. A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
• •3. History of allergic response(s) to mannitol, sucralose or related drugs.
• •4. History of clinically significant allergies including drug allergies or allergic bronchial asthma.
• •5. Evidence of chronic or acute infectious diseases.
• •6. Any clinically significant illness or surgery during the one month prior to Period I dosing (as determined by the clinical investigator).
• •7. Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
• •8. Receiving any investigational drug within one month prior to Period I dosing.
• •9. Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
• •10. Donating greater than 150 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
• •11. Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol, smoke or use tobacco products within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
• •12. Any other medical reason as determined by the clinical investigator.
• •13. Subject is pregnant or breastfeeding.
• •14. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.