Repeated Dosing Clinical Trial of HL151

NCT02686294 | Completed Phase 1

• 1 other identifier: HL-BPSR-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants with adverse events

  During 4 days' repeated dosing and post-study visit(within 5 days from discharge)

Study Arms (2)

T-R

EXPERIMENTAL

First period : administration of test drug Second period : administration of reference drug

Drug: HL151; Drug: TALION tab.

R-T

EXPERIMENTAL

First period : administration of reference drug Second period : administration of test drug

Drug: HL151; Drug: TALION tab.

Interventions

HL151 DRUG

Test drug : HL151. 1T, once a day oral administration, for 4 days

R-T; T-R

TALION tab. DRUG

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

R-T; T-R

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

The Korea Univertisy Anam Hospital

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ji young Park, MD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 19, 2016
• Study Start: February 16, 2016
• Primary Completion: March 15, 2016
• Study Completion: March 15, 2016
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

KR (1)