Single Dosing Clinical Trial of HL151
- Registration Number
- NCT02682745
- Lead Sponsor
- Hanlim Pharm. Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
- Healthy male volunteer in the age of 19-45
- Body weight≥50kg and BMI 18~29 kg/m2
- Subject who sign on an informed consent form willingly
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Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
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Subject with acute disease within 28 days prior to study medication dosing
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Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
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Subject with clinically significant chronic disease
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Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
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Use of any prescription medication within 14 days prior to study medication dosing
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Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
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Subject with clinically significant allergic disease
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Subject with known for hypersensitivity reaction to bepotastine
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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
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Immunological incompetence, immune deficiency or taking immunosuppressants
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Subject who cannot take standard meal
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Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
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Subject with blood transfusion within 30days prior to study medication dosing
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Participation in any clinical investigation within 90days prior to study medication dosing
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Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
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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
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Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
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Subject who are not using adequate means of contraception
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Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
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Subject with history of drug abuse or drug addiction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description T1-T2-R TALION tab. First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug T2-T1-R TALION tab. First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug R-T2-T1 HL151 First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l R-T1-T2 TALION tab. First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll T1-R-T2 HL151 First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll T2-R-T1 HL151 First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l R-T2-T1 TALION tab. First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l T1-R-T2 TALION tab. First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll T2-R-T1 TALION tab. First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l T1-T2-R HL151 First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug T2-T1-R HL151 First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug R-T1-T2 HL151 First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) 24 hours after single administration Peak Plasma Concentration (Cmax) 24 hours after single administration
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The Korea Univertisy Anam Hospital
🇰🇷Seoul, Korea, Republic of