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A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

NCT ID: NCT01573663

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Ambroxol Levodropropizine Drug-drug interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ambroxol and Levodropropizine

Group Type EXPERIMENTAL

Ambroxol and Levodropropizine

Intervention Type DRUG

Ambroxol HCl 30mg \& Levodropropizine 60mg, PO, Single dose

Ambroxol

Group Type ACTIVE_COMPARATOR

Ambroxol

Intervention Type DRUG

Ambroxol HCl 30mg, PO, single dose

Levodropropizine

Group Type ACTIVE_COMPARATOR

Levodropropizine

Intervention Type DRUG

Levodropropizine 60mg, PO, single dose

Interventions

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Ambroxol and Levodropropizine

Ambroxol HCl 30mg \& Levodropropizine 60mg, PO, Single dose

Intervention Type DRUG

Ambroxol

Ambroxol HCl 30mg, PO, single dose

Intervention Type DRUG

Levodropropizine

Levodropropizine 60mg, PO, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wooseong Huh, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-AMBLE-101

Identifier Type: -

Identifier Source: org_study_id