Single Dosing Clinical Trial of HL151

NCT ID: NCT02682745

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2016-02-12

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.

Conditions

Rhinitis, Allergic, Perennial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-T1-T2

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

Group Type: EXPERIMENTAL

HL151

Intervention Type: DRUG

Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal

TALION tab.

Intervention Type: DRUG

Reference drug: TALION tab, 1T, every 12 hours, oral administration

R-T2-T1

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

Group Type: EXPERIMENTAL

HL151

Intervention Type: DRUG

Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal

TALION tab.

Intervention Type: DRUG

Reference drug: TALION tab, 1T, every 12 hours, oral administration

T1-T2-R

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

Group Type: EXPERIMENTAL

HL151

Intervention Type: DRUG

Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal

TALION tab.

Intervention Type: DRUG

Reference drug: TALION tab, 1T, every 12 hours, oral administration

T1-R-T2

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

Group Type: EXPERIMENTAL

HL151

Intervention Type: DRUG

Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal

TALION tab.

Intervention Type: DRUG

Reference drug: TALION tab, 1T, every 12 hours, oral administration

T2-R-T1

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

Group Type: EXPERIMENTAL

HL151

Intervention Type: DRUG

Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal

TALION tab.

Intervention Type: DRUG

Reference drug: TALION tab, 1T, every 12 hours, oral administration

T2-T1-R

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

Group Type: EXPERIMENTAL

HL151

Intervention Type: DRUG

Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal

TALION tab.

Intervention Type: DRUG

Reference drug: TALION tab, 1T, every 12 hours, oral administration

Interventions

HL151

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

TALION tab.

Reference drug: TALION tab, 1T, every 12 hours, oral administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Korea Univertisy Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HL-BPSR-101

Identifier Type: -

Identifier Source: org_study_id