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Completed

NCT Number: NCT01423721

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

65.129.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female volunteers

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

Bromihexine hydrochloride syrup

Drug

syrup

Bromihexine hydrochloride granules

Drug

granules

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
First posted
Aug 26, 2011
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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