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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.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01423721
First received: August 25, 2011
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 Pharmaceuticals:

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 ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) [ Time Frame: 48 h ] [ Designated as safety issue: No ]

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
granules
Experimental: Bromihexine hydrochloride syrup
16 mg syrup
 Drug: Bromihexine hydrochloride syrup
syrup

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

- Healthy male and female volunteers

Exclusion criteria:

- Any relevant deviation from healthy conditions

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

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

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01423721     History of Changes
Other Study ID Numbers: 65.129, 2011-002733-19
Study First Received: August 25, 2011
Last Updated: April 4, 2012
Health Authority: Germany:

Additional relevant MeSH terms:
Bromhexine
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013