- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686294
Repeated Dosing Clinical Trial of HL151
August 16, 2018 updated by: Hanlim Pharm. Co., Ltd.
Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 136-705
- The Korea Univertisy Anam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T-R
First period : administration of test drug Second period : administration of reference drug
|
Test drug : HL151.
1T, once a day oral administration, for 4 days
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
|
Test drug : HL151.
1T, once a day oral administration, for 4 days
Reference drug : TALION tab.
1T, twice a day oral administration, for 4 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)
Time Frame: 24 hours after 4 days' repeated dosing
|
24 hours after 4 days' repeated dosing
|
Maximum the plasma concentration during a dosing interval(Cmax,ss)
Time Frame: 24 hours after 4 days' repeated dosing
|
24 hours after 4 days' repeated dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events
Time Frame: During 4 days' repeated dosing and post-study visit(within 5 days from discharge)
|
During 4 days' repeated dosing and post-study visit(within 5 days from discharge)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ji young Park, MD, Korea University Anam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2016
Primary Completion (Actual)
March 15, 2016
Study Completion (Actual)
March 15, 2016
Study Registration Dates
First Submitted
February 3, 2016
First Submitted That Met QC Criteria
February 15, 2016
First Posted (Estimate)
February 19, 2016
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 16, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL-BPSR-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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