Repeated Dosing Clinical Trial of HL151

Phase 1

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: HL151; Drug: TALION tab.

• Registration Number: NCT02686294
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-15
• Study Start: 2016-02-16
• Study First Posted: 2016-02-19
• Primary Completion: 2016-03-15
• Study Completion: 2016-03-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Healthy male in the age of 19-45
2. Body weight ≥ 50kg, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
T-R	HL151	First period : administration of test drug Second period : administration of reference drug
R-T	HL151	First period : administration of reference drug Second period : administration of test drug
R-T	TALION tab.	First period : administration of reference drug Second period : administration of test drug
T-R	TALION tab.	First period : administration of test drug Second period : administration of reference drug

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)	24 hours after 4 days' repeated dosing
Maximum the plasma concentration during a dosing interval(Cmax,ss)	24 hours after 4 days' repeated dosing

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	During 4 days' repeated dosing and post-study visit(within 5 days from discharge)

Trial Locations

Locations (1)

The Korea Univertisy Anam Hospital; 🇰🇷 Seoul, Korea, Republic of