Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges in Healthy Male Volunteers
NCT02194283 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2014-07-23
Summary
The main objectives of the present study are to determine pharmacokinetics of ambroxol in healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for four days
Conditions
- Healthy
Interventions
- DRUG
-
Ambroxol - in single rising doses
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2009-11-30
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