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

NCT ID: NCT01651481

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Rhinitis

Keywords

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Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TR

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

Group Type EXPERIMENTAL

HCP1102

Intervention Type DRUG

Singulair and Xyzal

Intervention Type DRUG

RT

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

Group Type EXPERIMENTAL

HCP1102

Intervention Type DRUG

Singulair and Xyzal

Intervention Type DRUG

Interventions

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HCP1102

Intervention Type DRUG

Singulair and Xyzal

Intervention Type DRUG

Other Intervention Names

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Singulair and Xyzal combination tablet coadministration of Singulair and Xyzal

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-MOLZ-102

Identifier Type: -

Identifier Source: org_study_id