PK and Safety Study of HCP1102, HGP0813 and HGP1408
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 2017
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2017
CompletedFirst Submitted
Initial submission to the registry
November 24, 2017
CompletedFirst Posted
Study publicly available on registry
December 13, 2017
CompletedDecember 13, 2017
December 1, 2017
15 days
November 24, 2017
December 8, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Group 1
EXPERIMENTALReference Drug → Test Drug
Group 2
EXPERIMENTALTest Drug → Reference Drug
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~45 years in healthy male volunteers
- BMI is more than 19kg/m\^2 , no more than 28.0 kg/m\^2
- 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
You may not qualify if:
- 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
- Subjects who judged ineligible by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Related Publications (1)
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: 32271144DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2017
First Posted
December 13, 2017
Study Start
July 19, 2017
Primary Completion
August 3, 2017
Study Completion
August 3, 2017
Last Updated
December 13, 2017
Record last verified: 2017-12