A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

Open Label, Randomized, 3-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Ambroxol HCl and Levodropropizine in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01573663

Enrollment

Registered

2012-04-09

Start date

2012-02-29

Completion date

2012-04-30

Last updated

2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Ambroxol, Levodropropizine, Drug-drug interaction

Brief summary

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

Interventions

DRUGAmbroxol and Levodropropizine

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

DRUGAmbroxol

Ambroxol HCl 30mg, PO, single dose

DRUGLevodropropizine

Levodropropizine 60mg, PO, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUClast	0-48hrs
Cmax	0-48hrs

Secondary

Measure	Time frame
Tmax	0-48hrs
T1/2	0-48hrs
AUCinf	0-48hrs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026