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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651481
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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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

Condition or disease Intervention/treatment Phase
Rhinitis Drug: HCP1102 Drug: Singulair and Xyzal Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TR
HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal
 Drug: HCP1102
Other Name: Singulair and Xyzal combination tablet

Drug: Singulair and Xyzal
Other Name: coadministration of Singulair and Xyzal
Experimental: RT
coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet)
 Drug: HCP1102
Other Name: Singulair and Xyzal combination tablet

Drug: Singulair and Xyzal
Other Name: coadministration of Singulair and Xyzal


Outcome Measures
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Primary Outcome Measures :
  1. AUClast [ Time Frame: 0-34hr ]
  2. Cmax [ Time Frame: 0-34hr ]

Secondary Outcome Measures :
  1. tmax [ Time Frame: 0-34hr ]
  2. AUCinf [ Time Frame: 0-34hr ]
  3. t1/2 [ Time Frame: 0-34hr ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651481


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01651481    
Other Study ID Numbers: HM-MOLZ-102
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013
Keywords provided by Hanmi Pharmaceutical Company Limited:
Rhinitis
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Montelukast
Levocetirizine
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents