A Drug Interaction Study of Montelukast and Levocetirizine | NCT01491503

Studies
A Drug Interaction Study of Montelukast and Levocetirizine

NCT01491503

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Apr 5, 2013Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

Levocetirizine
montelukast sodium
Montelukast & levocetirizine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Oct 14, 2011

First Submission Date that Met QC Criteria

Dec 13, 2011

First Posted Date

Dec 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2013

Last Update Posted Date

Apr 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Montelukast and levocetirizine	Experimental	Drug: Montelukast & levocetirizine
Montelukast	Active Comparator	Drug: montelukast sodium
Levocetirizine	Active Comparator	Drug: Levocetirizine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levocetirizine	Drug	Levocetirizine dihydrochloride 5mg. PO. Single dose.	Levocetirizine

Measure	Description	Time Frame
AUClast		0-36hrs
Cmax		0-36hrs

Measure	Description	Time Frame
Tmax		0-36hrs
T1/2		0-36hrs
AUCinf		0-36hrs

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wooseong Huh, MD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung medical center		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C472067	levocetirizine
C093875	montelukast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided