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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01423721
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : November 1, 2013
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Bromihexine hydrochloride syrup Drug: Bromihexine hydrochloride granules Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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)
Study Start Date : August 2011
Actual Primary Completion Date : October 2011

Arm Intervention/treatment
Experimental: Bromihexine hydrochloride granules
16 mg granules
Drug: Bromihexine hydrochloride granules
Experimental: Bromihexine hydrochloride syrup
16 mg syrup
Drug: Bromihexine hydrochloride syrup

Primary Outcome Measures :
  1. 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 ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 48 h ]

Secondary Outcome Measures :
  1. 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 ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423721

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

Responsible Party: Boehringer Ingelheim Identifier: NCT01423721     History of Changes
Other Study ID Numbers: 65.129
2011-002733-19 ( EudraCT Number: EudraCT )
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Respiratory System Agents