Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)

Relative Bioavailability of Bromhexine for Oral Administration of 16 mg of Bromhexine Hydrochloride Granules Compared to 16 mg of Bromhexine Hydrochloride Syrup in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Replicate Design Phase I Study With Two Treatments in Four Crossover Periods)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01423721

Enrollment

Registered

2011-08-26

Start date

2011-08-31

Completion date

Unknown

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup

Interventions

DRUGBromihexine hydrochloride syrup

syrup

DRUGBromihexine hydrochloride granules

granules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

\- Healthy male and female volunteers

Exclusion criteria

\- Any relevant deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame
AUC0-tz (area under the plasma concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)	48 h
Cmax (maximum measured concentration of the analyte in plasma)	48 h

Secondary

Measure	Time frame
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)	48 h

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026