A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ambroxol and Levodropropizine; Drug: Ambroxol; Drug: Levodropropizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573663

HM-AMBLE-101

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Ambroxol and Levodropropizine

Experimental group

Treatment:

Drug: Ambroxol and Levodropropizine

Ambroxol

Active Comparator group

Treatment:

Drug: Ambroxol

Levodropropizine

Active Comparator group

Treatment:

Drug: Levodropropizine