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Repeated Dosing Clinical Trial of HL151

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ClinicalTrials.gov Identifier: NCT02686294
Recruitment Status : Unknown
Verified February 2016 by Hanlim Pharm. Co., Ltd..
Recruitment status was:  Recruiting
First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: HL151 Drug: TALION tab. Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
Study Start Date : February 2016
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: T-R
First period : administration of test drug Second period : administration of reference drug
Drug: HL151
Test drug : HL151. 1T, once a day oral administration, for 4 days

Drug: TALION tab.
Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days

Experimental: R-T
First period : administration of reference drug Second period : administration of test drug
Drug: HL151
Test drug : HL151. 1T, once a day oral administration, for 4 days

Drug: TALION tab.
Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss) [ Time Frame: 24 hours after 4 days' repeated dosing ]
  2. Maximum the plasma concentration during a dosing interval(Cmax,ss) [ Time Frame: 24 hours after 4 days' repeated dosing ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: During 4 days' repeated dosing and post-study visit(within 5 days from discharge) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686294


Contacts
Contact: Ji young Park, MD 82-2-920-6468

Locations
Korea, Republic of
The Korea Univertisy Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Ji Young Park, Ph.D.    82-2-920-6468      
Principal Investigator: Ji Young Park, Ph.D.         
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
Principal Investigator: Ji young Park, MD Korea University Anam Hospital

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02686294     History of Changes
Other Study ID Numbers: HL-BPSR-102
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases