PK and Safety Study of HCP1102, HGP0813 and HGP1408

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: montelukast and levocetirizine FDC; Drug: Singulair + xyzal

• Registration Number: NCT03371849
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-19
• Primary Completion: 2017-08-03
• Study Completion: 2017-08-03
• Study First Submitted: 2017-11-24
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-08
• Last Update Submitted: 2017-12-08
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	montelukast and levocetirizine FDC	Test Drug → Reference Drug
Group 1	montelukast and levocetirizine FDC	Reference Drug → Test Drug
Group 1	Singulair + xyzal	Reference Drug → Test Drug
Group 2	Singulair + xyzal	Test Drug → Reference Drug

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of