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PK and Safety Study of HCP1102, HGP0813 and HGP1408

Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03371849
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
15
Actual Duration (Days)
48.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: montelukast and levocetirizine FDC
  • Drug: Singulair + xyzal
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Jul 19, 2017
Actual Primary Completion Date :
Aug 3, 2017
Actual Study Completion Date :
Aug 3, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Reference Drug → Test Drug

Drug: montelukast and levocetirizine FDC
HCP1102

Drug: Singulair + xyzal
HGP0813 + HGP1408
Experimental: Group 2

Test Drug → Reference Drug

Drug: montelukast and levocetirizine FDC
HCP1102

Drug: Singulair + xyzal
HGP0813 + HGP1408

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

  4. 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 Criteria

Criteria

Ages Eligible for Study:
19 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Age 19~45 years in healthy male volunteers

  2. BMI is more than 19kg/m2 , no more than 28.0 kg/m2

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chonbuk National University Hospital Jeonju Jeollabuk-do Korea, Republic of

Sponsors and Collaborators

  • Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT03371849
Other Study ID Numbers:
  • HM-MOLZ-103
First Posted:
Dec 13, 2017
Last Update Posted:
Dec 13, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Montelukast
Levocetirizine

Study Results

No Results Posted as of Dec 13, 2017