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Relative Bioavailability of Ambroxol Hydrochloride of Soft Pastilles Compared to Ambroxol Hydrochloride Syrup in Healthy Male and Female Volunteers

NCT02194270 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-07-18

No results posted yet for this study

Summary

Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15 mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state

Conditions

  • Healthy

Interventions

DRUG

Ambroxol hydrochloride - soft pastille

DRUG

Ambroxol hydrochloride - syrup - low dose

DRUG

Ambroxol hydrochloride - syrup - high dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2005-02-28

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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 NCT02194270 on ClinicalTrials.gov