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

NCT ID: NCT01423721

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bromihexine hydrochloride granules

16 mg granules

Group Type EXPERIMENTAL

Bromihexine hydrochloride granules

Intervention Type DRUG

granules

Bromihexine hydrochloride syrup

16 mg syrup

Group Type EXPERIMENTAL

Bromihexine hydrochloride syrup

Intervention Type DRUG

syrup

Interventions

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Bromihexine hydrochloride syrup

syrup

Intervention Type DRUG

Bromihexine hydrochloride granules

granules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Healthy male and female volunteers

Exclusion Criteria

\- Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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65.129.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-002733-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

65.129

Identifier Type: -

Identifier Source: org_study_id

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