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

August 25, 2011
October 31, 2013
August 2011
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01423721 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)
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)

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Bromihexine hydrochloride syrup
    syrup
  • Drug: Bromihexine hydrochloride granules
    granules
  • Experimental: Bromihexine hydrochloride granules
    16 mg granules
    Intervention: Drug: Bromihexine hydrochloride granules
  • Experimental: Bromihexine hydrochloride syrup
    16 mg syrup
    Intervention: Drug: Bromihexine hydrochloride syrup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
Not Provided
October 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

- Healthy male and female volunteers

Exclusion criteria:

- Any relevant deviation from healthy conditions

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01423721
65.129, 2011-002733-19
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP