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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Bromihexine hydrochloride granules; Drug: Bromihexine hydrochloride syrup

• Registration Number: NCT01423721
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Primary Completion: 2011-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bromihexine hydrochloride granules	Bromihexine hydrochloride granules	16 mg granules
Bromihexine hydrochloride syrup	Bromihexine hydrochloride syrup	16 mg syrup

Primary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	48 h
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

65.129.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany