PK and Safety Study of HCP1102, HGP0813 and HGP1408

NCT03371849 — Phase 1, Completed, 24 participants, Hanmi Pharmaceutical Company Limited

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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

Registry	NCT03371849
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	24 (Actual)
Sponsor	Hanmi Pharmaceutical Company Limited (Industry)
Conditions	Healthy
Interventions	montelukast and levocetirizine FDC, Singulair + xyzal (Drug)
Dates	start 2017-07-19, primary completion 2017-08-03, completion 2017-08-03, first posted 2017-12-13, last updated 2017-12-13
Locations	1 site in South Korea

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Group 1	Experimental	Drug: montelukast and levocetirizine FDC; Drug: Singulair + xyzal	Reference Drug → Test Drug
Group 2	Experimental	Drug: montelukast and levocetirizine FDC; Drug: Singulair + xyzal	Test Drug → Reference Drug

montelukast and levocetirizine FDC (Drug): HCP1102
Singulair + xyzal (Drug): HGP0813 + HGP1408

+Outcome measures

Primary outcomes

AUClast of Montelukast [1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour]
Cmax of Montelukast [1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour]
AUClast of Levocetirizine [1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour]
Cmax of Levocetirizine [1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour]

+Eligibility

Sex: Male, ages: 19 Years to 45 Years, 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

+Locations (1)

Facility	City	Country	Status
Chonbuk National University Hospital	Jeonju, Jeollabuk-do	South Korea

+Publications

Results publication: 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. PMID 32271144

My Notes

Public

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