PK and Safety Study of HCP1102, HGP0813 and HGP1408

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Singulair + xyzal; Drug: montelukast and levocetirizine FDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03371849

HM-MOLZ-103

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group 1

Experimental group

Description:

Reference Drug → Test Drug

Treatment:

Drug: montelukast and levocetirizine FDC

Drug: Singulair + xyzal

Group 2

Experimental group

Description:

Test Drug → Reference Drug

Treatment:

Drug: montelukast and levocetirizine FDC

Drug: Singulair + xyzal