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Single 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
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Korea Univertisy Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

R-T1-T2

R-T2-T1

T1-T2-R

T1-R-T2

T2-R-T1

T2-T1-R

Arm Description

First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll

First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l

First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug

First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll

First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l

First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC)
Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Number of participants with adverse events

Full Information

First Posted
February 3, 2016
Last Updated
August 16, 2018
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02682745
Brief Title
Single Dosing Clinical Trial of HL151
Official Title
Single 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
January 15, 2016 (Actual)
Primary Completion Date
February 12, 2016 (Actual)
Study Completion Date
February 12, 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 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.

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
R-T1-T2
Arm Type
Experimental
Arm Description
First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll
Arm Title
R-T2-T1
Arm Type
Experimental
Arm Description
First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l
Arm Title
T1-T2-R
Arm Type
Experimental
Arm Description
First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug
Arm Title
T1-R-T2
Arm Type
Experimental
Arm Description
First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll
Arm Title
T2-R-T1
Arm Type
Experimental
Arm Description
First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l
Arm Title
T2-T1-R
Arm Type
Experimental
Arm Description
First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug
Intervention Type
Drug
Intervention Name(s)
HL151
Intervention Description
Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal
Intervention Type
Drug
Intervention Name(s)
TALION tab.
Intervention Description
Reference drug: TALION tab, 1T, every 12 hours, oral administration
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
24 hours after single administration
Title
Peak Plasma Concentration (Cmax)
Time Frame
24 hours after single administration
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
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

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 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 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
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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Single Dosing Clinical Trial of HL151

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