A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ambroxol and Levodropropizine; Drug: Ambroxol; Drug: Levodropropizine

• Registration Number: NCT01573663
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-09
• Last Update Submitted: 2012-07-18
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ambroxol and Levodropropizine	Ambroxol and Levodropropizine	-
Ambroxol	Ambroxol	-
Levodropropizine	Levodropropizine	-

Primary Outcome Measures

Name	Time	Method
AUClast	0-48hrs
Cmax	0-48hrs

Secondary Outcome Measures

Name	Time	Method
Tmax	0-48hrs
T1/2	0-48hrs
AUCinf	0-48hrs

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of