Single Dosing Clinical Trial of HL151

NCT02682745 | Completed Phase 1

• 1 other identifier: HL-BPSR-101
• 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 single 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 versus time curve (AUC)

  24 hours after single administration

• Peak Plasma Concentration (Cmax)

  24 hours after single administration

Secondary Outcomes (1)

• Number of participants with adverse events

  Participants will be followed for the duration of study medication dosing days and hospital stay, and follow-up period for maximum 5 days from the discharge

Study Arms (6)

R-T1-T2

EXPERIMENTAL

First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll

Drug: HL151; Drug: TALION tab.

R-T2-T1

EXPERIMENTAL

First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l

Drug: HL151; Drug: TALION tab.

T1-T2-R

EXPERIMENTAL

First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug

Drug: HL151; Drug: TALION tab.

T1-R-T2

EXPERIMENTAL

First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll

Drug: HL151; Drug: TALION tab.

T2-R-T1

EXPERIMENTAL

First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l

Drug: HL151; Drug: TALION tab.

T2-T1-R

EXPERIMENTAL

First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug

Drug: HL151; Drug: TALION tab.

Interventions

HL151 DRUG

Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal

R-T1-T2; R-T2-T1; T1-R-T2; T1-T2-R; T2-R-T1; T2-T1-R

TALION tab. DRUG

Reference drug: TALION tab, 1T, every 12 hours, oral administration

R-T1-T2; R-T2-T1; T1-R-T2; T1-T2-R; T2-R-T1; T2-T1-R

Eligibility Criteria

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

You may qualify if:

• Healthy male volunteer in the age of 19-45
• Body weight≥50kg and 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 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 15, 2016
• Study Start: January 15, 2016
• Primary Completion: February 12, 2016
• Study Completion: February 12, 2016
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

KR (1)