A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

July 18, 2012 updated by: Hanmi Pharmaceutical Company Limited

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUClast
Time Frame: 0-48hrs
0-48hrs
Cmax
Time Frame: 0-48hrs
0-48hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Tmax
Time Frame: 0-48hrs
0-48hrs
T1/2
Time Frame: 0-48hrs
0-48hrs
AUCinf
Time Frame: 0-48hrs
0-48hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Wooseong Huh, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 9, 2012

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-AMBLE-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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