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Investigation of the Metabolism and Pharmacokinetics of Ambroxol in Healthy Male Volunteers

NCT02194257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-07-18

No results posted yet for this study

Summary

Study to determine the basic pharmacokinetics of ambroxol and \[14C\]-radioactivity including mass balance, excretion pathways and complete metabolism in healthy male volunteers following administration of a lozenge of 20 mg ambroxol together with an oral solution of 0.4 mg \[14C\]-ambroxol labelled in two different positions

Conditions

  • Healthy

Interventions

DRUG

[14C]-cyclohexane ambroxol oral solution

DRUG

[14C]-benzyl ambroxol oral solution

DRUG

Ambroxol lozenge

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02194257 on ClinicalTrials.gov