Single Dosing Clinical Trial of HL151

• Sponsor: Hanlim Pharm. Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02682745
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 6
• Actual Duration (Days): 28
• Patients Per Site Per Month: 32.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Perennial	Drug: HL151; Drug: TALION tab.	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
• Actual Study Start Date: Jan 15, 2016
• Actual Primary Completion Date: Feb 12, 2016
• Actual Study Completion Date: Feb 12, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R-T1-T2 First period: administration of reference drug, Second period: administration of test drug l, Third period : administration of test drug ll	Drug: HL151; Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal; Drug: TALION tab.; Reference drug: TALION tab, 1T, every 12 hours, oral administration
Experimental: R-T2-T1 First period : administration of reference drug, Second period : administration of test drug ll, Third period : administration of test drug l	Drug: HL151; Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal; Drug: TALION tab.; Reference drug: TALION tab, 1T, every 12 hours, oral administration
Experimental: T1-T2-R First period : administration of test drug l, Second period : administration of test drug ll, Third period : administration of reference drug	Drug: HL151; Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal; Drug: TALION tab.; Reference drug: TALION tab, 1T, every 12 hours, oral administration
Experimental: T1-R-T2 First period : administration of test drug l, Second period : administration of reference drug, Third period : administration of test drug ll	Drug: HL151; Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal; Drug: TALION tab.; Reference drug: TALION tab, 1T, every 12 hours, oral administration
Experimental: T2-R-T1 First period : administration of test drug ll, Second period : administration of reference drug, Third period : administration of test drug l	Drug: HL151; Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal; Drug: TALION tab.; Reference drug: TALION tab, 1T, every 12 hours, oral administration
Experimental: T2-T1-R First period : administration of test drug ll, Second period : administration of test drug l, Third period : administration of reference drug	Drug: HL151; Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal; Drug: TALION tab.; Reference drug: TALION tab, 1T, every 12 hours, oral administration

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration versus time curve (AUC) [24 hours after single administration]

2. Peak Plasma Concentration (Cmax) [24 hours after single administration]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy male volunteer in the age of 19-45

2. Body weight≥50kg and 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

1. Immunological incompetence, immune deficiency or taking immunosuppressants

2. Subject who cannot take standard meal

3. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing

4. Subject with blood transfusion within 30days prior to study medication dosing

5. Participation in any clinical investigation within 90days prior to study medication dosing

6. Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)

7. 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

8. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing

9. Subject who are not using adequate means of contraception

10. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption

11. Subject with history of drug abuse or drug addiction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Korea Univertisy Anam Hospital	Seoul		Korea, Republic of	136-705

Sponsors and Collaborators

• Hanlim Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanlim Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02682745
• Other Study ID Numbers: HL-BPSR-101
• First Posted: Feb 15, 2016
• Last Update Posted: Aug 17, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial

Study Results

No Results Posted as of Aug 17, 2018