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Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride

NCT02572609 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-12-31

Study results available
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Summary

to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation), manufactured by Bolder Arzneimittel GmbH \& Co. KG to Boehringer Ingelheim compared to ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda.

Conditions

  • Healthy

Interventions

DRUG

Ambroxol hydrochloride soft pastille

DRUG

Mucosolvan ® adult syrup

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

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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 NCT02572609 on ClinicalTrials.gov