Rhinitis, Allergic, Perennial
Conditions
Brief summary
The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Interventions
DRUGHL151
Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal
DRUGTALION tab.
Reference drug: TALION tab, 1T, every 12 hours, oral administration
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male volunteer in the age of 19-45 2. Body weight≥50kg and BMI 18\ 29 kg/m2 3. Subject who sign on an informed consent form willingly
Exclusion criteria
1. Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease 2. Subject with acute disease within 28 days prior to study medication dosing 3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug 4. Subject with clinically significant chronic disease 5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL 6. Use of any prescription medication within 14 days prior to study medication dosing 7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing 8. Subject with clinically significant allergic disease 9. Subject with known for hypersensitivity reaction to bepotastine 10. Subject with any of the following conditions in laboratory test * AST/ALT \> UNL (upper normal limit) x 2 * Total bilirubin \> UNL x 2 * Renal failure with CLcr \< 50mL/min calculated on Cockcroft-Gault \[Cockcroft-Gault GFR = (140-age) \* (Wt in kg) / (72 \*Cr)\] * SBP\<100mmHg or ≥160mmHg, DBP\<60mmHg or ≥100mmHg * QTc\>440msec on ECG * Serum potassium \< 3.5 mEq/L or \> 5.5 mEq/L 11. Immunological incompetence, immune deficiency or taking immunosuppressants 12. Subject who cannot take standard meal 13. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing 14. Subject with blood transfusion within 30days prior to study medication dosing 15. Participation in any clinical investigation within 90days prior to study medication dosing 16. Continued excessive use of caffeine (caffeine \>five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \>10 cigarettes per day) 17. Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator 18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing 19. Subject who are not using adequate means of contraception 20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption 21. Subject with history of drug abuse or drug addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) | 24 hours after single administration |
| Peak Plasma Concentration (Cmax) | 24 hours after single administration |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Participants will be followed for the duration of study medication dosing days and hospital stay, and follow-up period for maximum 5 days from the discharge |
Countries
South Korea
Outcome results
None listed