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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
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:

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

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUClast [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01573663     History of Changes
Other Study ID Numbers: HM-AMBLE-101
Study First Received: April 5, 2012
Last Updated: July 18, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Ambroxol
Dipropizine
Expectorants
Respiratory System Agents
 Therapeutic Uses
Pharmacologic Actions
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013