Repeated Dosing Clinical Trial of HL151
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL151
TALION tab.
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial
Eligibility Criteria
Inclusion Criteria:
- Healthy male in the age of 19-45
- Body weight ≥ 50kg, BMI 18~29 kg/m2
- Subject who sign on an informed consent form willingly
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
- 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
- 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
Sites / Locations
- The Korea Univertisy Anam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
T-R
R-T
Arm Description
First period : administration of test drug Second period : administration of reference drug
First period : administration of reference drug Second period : administration of test drug
Outcomes
Primary Outcome Measures
Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)
Maximum the plasma concentration during a dosing interval(Cmax,ss)
Secondary Outcome Measures
Number of participants with adverse events
Full Information
NCT ID
NCT02686294
First Posted
February 3, 2016
Last Updated
August 16, 2018
Sponsor
Hanlim Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02686294
Brief Title
Repeated Dosing Clinical Trial of HL151
Official Title
Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 16, 2016 (Actual)
Primary Completion Date
March 15, 2016 (Actual)
Study Completion Date
March 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T-R
Arm Type
Experimental
Arm Description
First period : administration of test drug Second period : administration of reference drug
Arm Title
R-T
Arm Type
Experimental
Arm Description
First period : administration of reference drug Second period : administration of test drug
Intervention Type
Drug
Intervention Name(s)
HL151
Intervention Description
Test drug : HL151. 1T, once a day oral administration, for 4 days
Intervention Type
Drug
Intervention Name(s)
TALION tab.
Intervention Description
Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)
Time Frame
24 hours after 4 days' repeated dosing
Title
Maximum the plasma concentration during a dosing interval(Cmax,ss)
Time Frame
24 hours after 4 days' repeated dosing
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
During 4 days' repeated dosing and post-study visit(within 5 days from discharge)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male in the age of 19-45
Body weight ≥ 50kg, BMI 18~29 kg/m2
Subject who sign on an informed consent form willingly
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
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji young Park, MD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Korea Univertisy Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
12. IPD Sharing Statement
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Repeated Dosing Clinical Trial of HL151
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