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

Brief Summary:
The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ambroxol and Levodropropizine Drug: Ambroxol Drug: Levodropropizine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
Study Start Date : February 2012
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. AUClast [ Time Frame: 0-48hrs ]
  2. Cmax [ Time Frame: 0-48hrs ]

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

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

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

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 identifier (NCT number): NCT01573663

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

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01573663     History of Changes
Other Study ID Numbers: HM-AMBLE-101
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Respiratory System Agents
Antitussive Agents