MedDataX Logo

PK and Safety Study of HCP1102, HGP0813 and HGP1408

NCT ID: NCT03371849

Last Updated: 2017-12-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

montelukast and levocetirizine FDC

HCP1102

Intervention Type DRUG

Singulair + xyzal

HGP0813 + HGP1408

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Moon SJ, Yu KS, Jung J, Kim YI, Kim MG. Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects . Int J Clin Pharmacol Ther. 2020 Jun;58(6):354-362. doi: 10.5414/CP203709.

Reference Type DERIVED
PMID: 32271144 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM-MOLZ-103

Identifier Type: -

Identifier Source: org_study_id