A Drug Interaction Study of Montelukast and Levocetirizine | RxWiki

A Drug Interaction Study of Montelukast and Levocetirizine

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.
Condition	Healthy
Intervention	Drug: Levocetirizine Drug: montelukast sodium Drug: Montelukast & levocetirizine
Phase	Phase 1
Sponsor	Hanmi Pharmaceutical Company Limited
Responsible Party	Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier	NCT01491503
First Received	October 14, 2011
Last Updated	April 4, 2013
Last verified	April 2013

Tracking Information[ + expand ][ + ]

First Received Date	October 14, 2011
Last Updated Date	April 4, 2013
Start Date	November 2011
Estimated Primary Completion Date	January 2012
Current Primary Outcome Measures	AUClast [Time Frame: 0-36hrs] [Designated as safety issue: No] Cmax [Time Frame: 0-36hrs] [Designated as safety issue: No]
Current Secondary Outcome Measures	Tmax [Time Frame: 0-36hrs] [Designated as safety issue: No] T1/2 [Time Frame: 0-36hrs] [Designated as safety issue: No] AUCinf [Time Frame: 0-36hrs] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Drug Interaction Study of Montelukast and Levocetirizine
Official Title	Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers
Brief Summary	The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	Drug: Levocetirizine Levocetirizine dihydrochloride 5mg. PO. Single dose. Drug: montelukast sodium Montelukast sodium 10mg. PO. Single dose. Drug: Montelukast & levocetirizine Montelukast sodium 10mg & levocetirizine dihydrochloride 5mg PO. Single dose.
Study Arm (s)	Experimental: Montelukast and levocetirizine Active Comparator: Montelukast Active Comparator: Levocetirizine

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	30
Estimated Completion Date	January 2012
Estimated Primary Completion Date	January 2012
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 14days of screening
Gender	Male
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01491503
Other Study ID Numbers	HM-MOLZ-101
Has Data Monitoring Committee	No
Information Provided By	Hanmi Pharmaceutical Company Limited
Study Sponsor	Hanmi Pharmaceutical Company Limited
Collaborators	Not Provided
Investigators	Principal Investigator: Wooseong Huh, MD Samsung Medical Center
Verification Date	April 2013

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