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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Bromihexine hydrochloride syrup; Drug: Bromihexine hydrochloride granules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01423721

2011-002733-19 (EudraCT Number)

65.129

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female volunteers

Exclusion criteria

• Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Bromihexine hydrochloride granules

Experimental group

Description:

16 mg granules

Treatment:

Drug: Bromihexine hydrochloride granules

Bromihexine hydrochloride syrup

Experimental group

Description:

16 mg syrup

Treatment:

Drug: Bromihexine hydrochloride syrup