Back to results

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.

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:

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

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

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

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

Learn more about this trial

Repeated Dosing Clinical Trial of HL151

We'll reach out to this number within 24 hrs