PK and Safety Study of HCP1102, HGP0813 and HGP1408

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2017-08-03

Brief Summary

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This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 administered in healthy male volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

Reference Drug → Test Drug

Group Type EXPERIMENTAL

montelukast and levocetirizine FDC

Intervention Type DRUG

HCP1102

Singulair + xyzal

Intervention Type DRUG

HGP0813 + HGP1408

Group 2

Test Drug → Reference Drug

Group Type EXPERIMENTAL

montelukast and levocetirizine FDC

Intervention Type DRUG

HCP1102

Singulair + xyzal

Intervention Type DRUG

HGP0813 + HGP1408

Interventions

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montelukast and levocetirizine FDC

HCP1102

Intervention Type DRUG

Singulair + xyzal

HGP0813 + HGP1408

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 19\~45 years in healthy male volunteers
2. BMI is more than 19kg/m\^2 , no more than 28.0 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes