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

Boehringer Ingelheim39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Bromihexine hydrochloride syrupDRUG

syrup

Bromihexine hydrochloride granulesDRUG

granules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: \- Healthy male and female volunteers Exclusion criteria: \- Any relevant deviation from healthy conditions

Locations (1)

65.129.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Outcomes

Primary Outcomes

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)

Time frame: 48 h

Cmax (maximum measured concentration of the analyte in plasma)

Time frame: 48 h

Secondary Outcomes

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

Time frame: 48 h

Data from ClinicalTrials.gov

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