Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)
2 other identifiers
interventional
39
1 country
1
Brief Summary
The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 25, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedNovember 1, 2013
October 1, 2013
2 months
August 25, 2011
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity)
48 h
Study Arms (2)
Bromihexine hydrochloride granules
EXPERIMENTAL16 mg granules
Bromihexine hydrochloride syrup
EXPERIMENTAL16 mg syrup
Interventions
Eligibility Criteria
You may qualify if:
- \- Healthy male and female volunteers
You may not qualify if:
- \- Any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
65.129.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2011
First Posted
August 26, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Last Updated
November 1, 2013
Record last verified: 2013-10