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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: August 25, 2011
Last updated: October 31, 2013
Last verified: October 2013
The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup

Condition Intervention Phase
Healthy Drug: Bromihexine hydrochloride syrup Drug: Bromihexine hydrochloride granules Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 39
Study Start Date: August 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bromihexine hydrochloride granules
16 mg granules
Drug: Bromihexine hydrochloride granules
Experimental: Bromihexine hydrochloride syrup
16 mg syrup
Drug: Bromihexine hydrochloride syrup


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

- Healthy male and female volunteers

Exclusion criteria:

- Any relevant deviation from healthy conditions

  Contacts and Locations
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Please refer to this study by its identifier: NCT01423721

65.129.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01423721     History of Changes
Other Study ID Numbers: 65.129
2011-002733-19 ( EudraCT Number: EudraCT )
Study First Received: August 25, 2011
Last Updated: October 31, 2013

Additional relevant MeSH terms:
Respiratory System Agents processed this record on August 22, 2017