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
ClinicalTrials.gov Identifier:
NCT01423721
First received: August 25, 2011
Last updated: October 31, 2013
Last verified: October 2013
  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:

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-infinity (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01423721     History of Changes
Other Study ID Numbers: 65.129, 2011-002733-19
Study First Received: August 25, 2011
Last Updated: October 31, 2013
Health Authority: Germany:

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

ClinicalTrials.gov processed this record on August 28, 2014