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A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01573663
First received: April 5, 2012
Last updated: July 18, 2012
Last verified: April 2012

April 5, 2012
July 18, 2012
February 2012
April 2012   (final data collection date for primary outcome measure)
  • AUClast [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01573663 on ClinicalTrials.gov Archive Site
  • Tmax [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
  • T1/2 [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
  • AUCinf [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
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
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01573663
HM-AMBLE-101
No
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