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

August 12, 2013 updated by: Hanmi Pharmaceutical Company Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TR
HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal
Drug: HCP1102
Other Names:
  • Singulair and Xyzal combination tablet
Drug: Singulair and Xyzal
Other Names:
  • coadministration of Singulair and Xyzal
Experimental: RT
coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet)
Drug: HCP1102
Other Names:
  • Singulair and Xyzal combination tablet
Drug: Singulair and Xyzal
Other Names:
  • coadministration of Singulair and Xyzal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast
Time Frame: 0-34hr
0-34hr
Cmax
Time Frame: 0-34hr
0-34hr

Secondary Outcome Measures

Outcome Measure
Time Frame
tmax
Time Frame: 0-34hr
0-34hr
AUCinf
Time Frame: 0-34hr
0-34hr
t1/2
Time Frame: 0-34hr
0-34hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 25, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 27, 2012

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 12, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-MOLZ-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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