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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014