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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-T1-T2 | Experimental | First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll |
|
| R-T2-T1 | Experimental | First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l |
|
| T1-T2-R | Experimental | First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug |
|
| T1-R-T2 | Experimental | First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll |
|
| T2-R-T1 | Experimental | First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL151 | Drug | Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
Subject with acute disease within 28 days prior to study medication dosing
Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
Subject with clinically significant chronic disease
Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
Use of any prescription medication within 14 days prior to study medication dosing
Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
Subject with clinically significant allergic disease
Subject with known for hypersensitivity reaction to bepotastine
Subject with any of the following conditions in laboratory test
Immunological incompetence, immune deficiency or taking immunosuppressants
Subject who cannot take standard meal
Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
Subject with blood transfusion within 30days prior to study medication dosing
Participation in any clinical investigation within 90days prior to study medication dosing
Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
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
Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
Subject who are not using adequate means of contraception
Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
Subject with history of drug abuse or drug addiction
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Korea Univertisy Anam Hospital | Seoul | 136-705 | South Korea |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| T2-T1-R | Experimental | First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug |
|
| TALION tab. | Drug | Reference drug: TALION tab, 1T, every 12 hours, oral administration |
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |