A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

Phase 1CompletedNCT01573663

Hanmi Pharmaceutical Company Limited21 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Ambroxol and LevodropropizineDRUG

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

AmbroxolDRUG

Ambroxol HCl 30mg, PO, single dose

LevodropropizineDRUG

Levodropropizine 60mg, PO, single dose

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung medical center

Seoul, South Korea

Outcomes

Primary Outcomes

AUClast

Time frame: 0-48hrs

Cmax

Time frame: 0-48hrs

Secondary Outcomes

Tmax

Time frame: 0-48hrs

T1/2

Time frame: 0-48hrs

AUCinf

Time frame: 0-48hrs

Data from ClinicalTrials.gov

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