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

Tracking Information
First Submitted Date ICMJE	August 25, 2011
First Posted Date ICMJE	August 26, 2011
Last Update Posted Date	November 1, 2013
Study Start Date ICMJE	August 2011
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 25, 2011)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01423721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 31, 2013)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: August 25, 2011)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)
Official Title ICMJE	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)
Brief Summary	The objective of the current study is to investigate relative bioavailability of bromhexine hydrochloride given as granules and syrup
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Healthy
Intervention ICMJE	Drug: Bromihexine hydrochloride syrup syrup; Drug: Bromihexine hydrochloride granules granules
Study Arms	Experimental: Bromihexine hydrochloride granules 16 mg granules Intervention: Drug: Bromihexine hydrochloride granules; Experimental: Bromihexine hydrochloride syrup 16 mg syrup Intervention: Drug: Bromihexine hydrochloride syrup
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 25, 2011)	39
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion criteria: - Healthy male and female volunteers Exclusion criteria: - Any relevant deviation from healthy conditions
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01423721
Other Study ID Numbers ICMJE	65.129; 2011-002733-19 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Boehringer Ingelheim
Study Sponsor ICMJE	Boehringer Ingelheim
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account	Boehringer Ingelheim
Verification Date	October 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP