Open Label, Randomized, 3-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Ambroxol HCl and Levodropropizine in Healthy Male Volunteers
| Registry | NCT01573663 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 21 (Actual) |
| Sponsor | Hanmi Pharmaceutical Company Limited (Industry) |
| Conditions | Healthy |
| Interventions | Ambroxol and Levodropropizine, Ambroxol, Levodropropizine (Drug) |
| Dates | start 2012-02-01, primary completion 2012-04-01, completion 2012-04-01, first posted 2012-04-09, last updated 2012-07-19 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of Ambroxol and Levodropropizine All trials of Ambroxol
The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ambroxol and Levodropropizine | Experimental | Drug: Ambroxol and Levodropropizine | |
| Ambroxol | Active comparator | Drug: Ambroxol | |
| Levodropropizine | Active comparator | Drug: Levodropropizine |
Sex: Male, ages: 20 Years to 55 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Samsung medical center | Seoul | South Korea |