Inclusion Criteria:

• Body Mass Index (BMI) between 18.5-30 kg/m2
• Vital signs: SBP 100-139 mmHg, DBP 50-89 mmHg, PR 50-90 bpm, measured after 5 min of rest (sitting position)
• Contraception (females only): use of highly effective contraceptive methods for at least 1 month prior to the study start of the trial according to the definition of Note 3 of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some Intra-Uterine Devices (IUDs), sexual abstinence or vasectomised partner); or women of not child-bearing potential (i.e. permanently sterilized since at least 3 months) or in post-menopausal status for at least 1 year
• Contraception (males only): the male study participants should agree to use contraceptive for one week after the dosing
• Ability to cooperate with the Investigator and to comply with the requirements of the entire study
• Non-smokers -which means non-smoking since at least three months prior to the
screening visit



Exclusion Criteria:

•Physical findings: clinically relevant abnormal physical examination findings which could interfere with the objectives of the study
• ECG (12 leads): clinically relevant abnormalities
• Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness
• Virology: positive HBs Ag, HCV Ab and HIV 1/2 assays
• Allergy: ascertained or presumptive hypersensitivity to the active pharmaceutical ingredient and/or formulation excipients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
• Diseases: clinically significant current or history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
• Current nasal abnormalities that may impact on the application or action of the investigational products, e.g. current perennial or seasonal allergic rhinitis, nasopharingitis, cold, or flu; Any clinically significant nasal anatomic abnormalities, such as severely deviated nasal septum, nasal polyps, completed blocked nostril, or history of nasal major surgeries
• Medications: Previous medication, including OTC (over-the-counter) and with the exception of oral contraceptives, within 14 days of the screening visit
• Investigative drug trials: participation in the evaluation of any investigational product within the following time period prior to the first dosing in the current study: 2 months or at least five half-lives of the previous investigational product, whichever is longer
• Blood donation: blood donations of any kind which exceeded 500mL of blood during the 3 months prior to study participation or if participation in this current study would cause a greater than 500ml blood loss over a period of 3 months
• Drug, alcohol, caffeine: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to USDA Dietary Guidelines 2005 (40) ] or caffeine (>5 cups coffee/tea/day). Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks
• Pregnancy: pregnant or lactating women
• Personnel: member or relative of the trial site staff or an employee of the Sponsor
• Participation: volunteers who already have taken part in the stage 1 of this study.