A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

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. Identifier: NCT01573663
Recruitment Status : Completed
First Posted : April 9, 2012
Last Update Posted : July 19, 2012
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

April 5, 2012
April 9, 2012
July 19, 2012
February 2012
April 2012   (Final data collection date for primary outcome measure)
  • AUClast [ Time Frame: 0-48hrs ]
  • Cmax [ Time Frame: 0-48hrs ]
Same as current
Complete list of historical versions of study NCT01573663 on Archive Site
  • Tmax [ Time Frame: 0-48hrs ]
  • T1/2 [ Time Frame: 0-48hrs ]
  • AUCinf [ Time Frame: 0-48hrs ]
Same as current
Not Provided
Not Provided
A Drug-Drug Interaction Study of Ambroxol and Levodropropizine
Open Label, Randomized, 3-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Ambroxol HCl and Levodropropizine in Healthy Male Volunteers
The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Ambroxol and Levodropropizine
    Ambroxol HCl 30mg & Levodropropizine 60mg, PO, Single dose
  • Drug: Ambroxol
    Ambroxol HCl 30mg, PO, single dose
  • Drug: Levodropropizine
    Levodropropizine 60mg, PO, single dose
  • Experimental: Ambroxol and Levodropropizine
    Intervention: Drug: Ambroxol and Levodropropizine
  • Active Comparator: Ambroxol
    Intervention: Drug: Ambroxol
  • Active Comparator: Levodropropizine
    Intervention: Drug: Levodropropizine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Wooseong Huh, MD Samsung Medical Center
Hanmi Pharmaceutical Company Limited
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP