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A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573663
First Posted: April 9, 2012
Last Update Posted: July 19, 2012
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.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  Purpose
The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.

Condition Intervention Phase
Healthy Drug: Ambroxol and Levodropropizine Drug: Ambroxol Drug: Levodropropizine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Randomized, 3-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Ambroxol HCl and Levodropropizine in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUClast [ Time Frame: 0-48hrs ]
  • Cmax [ Time Frame: 0-48hrs ]

Secondary Outcome Measures:
  • Tmax [ Time Frame: 0-48hrs ]
  • T1/2 [ Time Frame: 0-48hrs ]
  • AUCinf [ Time Frame: 0-48hrs ]

Enrollment: 21
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ambroxol and Levodropropizine Drug: Ambroxol and Levodropropizine
Ambroxol HCl 30mg & Levodropropizine 60mg, PO, Single dose
Active Comparator: Ambroxol Drug: Ambroxol
Ambroxol HCl 30mg, PO, single dose
Active Comparator: Levodropropizine Drug: Levodropropizine
Levodropropizine 60mg, PO, single dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 14 days of screening
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573663


Locations
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Wooseong Huh, MD Samsung Medical Center
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01573663     History of Changes
Other Study ID Numbers: HM-AMBLE-101
First Submitted: April 5, 2012
First Posted: April 9, 2012
Last Update Posted: July 19, 2012
Last Verified: April 2012

Keywords provided by Hanmi Pharmaceutical Company Limited:
Ambroxol
Levodropropizine
Drug-drug interaction

Additional relevant MeSH terms:
Ambroxol
Dipropizine
Expectorants
Respiratory System Agents
Antitussive Agents