Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Hyoscine butylbromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01734902

2012-003720-20 (EudraCT Number)

202.846

Details and patient eligibility

About

The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects

Exclusion criteria

1. 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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30 participants in 2 patient groups

1 Hyoscine butylbromide

Experimental group

Description:

drops, oral administration with 240 mL water

Treatment:

Drug: Hyoscine butylbromide

Drug: Hyoscine butylbromide

2 Hyoscine butylbromide

Experimental group

Description:

sugar coated tablets, oral administration with 240 mL water

Treatment:

Drug: Hyoscine butylbromide

Drug: Hyoscine butylbromide