Clinical trial NCT02686294: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-19
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)
timeFrame: 24 hours after 4 days' repeated dosing
measure: Maximum the plasma concentration during a dosing interval(Cmax,ss)
timeFrame: 24 hours after 4 days' repeated dosing
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: During 4 days' repeated dosing and post-study visit(within 5 days from discharge)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Korea Univertisy Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji young Park, MD
role: PRINCIPAL_INVESTIGATOR
References: