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
1 other identifier
interventional
21
1 country
1
Brief Summary
The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Feb 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 9, 2012
CompletedJuly 19, 2012
April 1, 2012
2 months
April 5, 2012
July 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUClast
0-48hrs
Cmax
0-48hrs
Secondary Outcomes (3)
Tmax
0-48hrs
T1/2
0-48hrs
AUCinf
0-48hrs
Study Arms (3)
Ambroxol and Levodropropizine
EXPERIMENTALAmbroxol
ACTIVE COMPARATORLevodropropizine
ACTIVE COMPARATORInterventions
Ambroxol HCl 30mg \& Levodropropizine 60mg, PO, Single dose
Eligibility Criteria
You may qualify if:
- Healthy male
- Age between 20 and 55
- Signed informed consent
You may not qualify if:
- Has a history of hypersensitivity to IP ingredients
- Hypotension or hypertension
- Has a history of acute infection within 14 days of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung medical center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wooseong Huh, MD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 9, 2012
Study Start
February 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
July 19, 2012
Record last verified: 2012-04