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Completed

NCT Number: NCT01491503

A Drug Interaction Study of Montelukast and Levocetirizine

The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung medical center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levocetirizine

Drug

Levocetirizine dihydrochloride 5mg. PO. Single dose.

montelukast sodium

Drug

Montelukast sodium 10mg. PO. Single dose.

Montelukast & levocetirizine

Drug

Montelukast sodium 10mg & levocetirizine dihydrochloride 5mg PO. Single dose.

Primary outcomes

  1. AUClast

    Time frame: 0-36hrs

  2. Cmax

    Time frame: 0-36hrs

Secondary outcomes

  1. Tmax

    Time frame: 0-36hrs

  2. T1/2

    Time frame: 0-36hrs

  3. AUCinf

    Time frame: 0-36hrs

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers

Acronym: MOLZ

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2011
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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