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Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination

Primary Purpose

Rhinitis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP1102
Singulair and Xyzal
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis focused on measuring Rhinitis

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male
  • Age between 20 and 55
  • Signed informed consent

Exclusion Criteria:

  • Has a history of hypersensitivity to IP ingredients
  • Hypotension or hypertension
  • Has a history of acute infection within 14 days of screening

Sites / Locations

  • Samsung medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TR

RT

Arm Description

HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal

coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet)

Outcomes

Primary Outcome Measures

AUClast
Cmax

Secondary Outcome Measures

tmax
AUCinf
t1/2

Full Information

First Posted
July 25, 2012
Last Updated
August 12, 2013
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01651481
Brief Title
Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination
Official Title
Open-label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics and Safety of Singulair (10 mg) and Xyzal (5 mg) in Free Combination and Fixed-dose Combination as HCP1102 in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis
Keywords
Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR
Arm Type
Experimental
Arm Description
HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal
Arm Title
RT
Arm Type
Experimental
Arm Description
coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet)
Intervention Type
Drug
Intervention Name(s)
HCP1102
Other Intervention Name(s)
Singulair and Xyzal combination tablet
Intervention Type
Drug
Intervention Name(s)
Singulair and Xyzal
Other Intervention Name(s)
coadministration of Singulair and Xyzal
Primary Outcome Measure Information:
Title
AUClast
Time Frame
0-34hr
Title
Cmax
Time Frame
0-34hr
Secondary Outcome Measure Information:
Title
tmax
Time Frame
0-34hr
Title
AUCinf
Time Frame
0-34hr
Title
t1/2
Time Frame
0-34hr

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male Age between 20 and 55 Signed informed consent Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypotension or hypertension Has a history of acute infection within 14 days of screening
Facility Information:
Facility Name
Samsung medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination

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