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

NCT ID: NCT01734902

Last Updated: 2019-04-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-01

Study Completion Date

2012-12-01

Brief Summary

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

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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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1 Hyoscine butylbromide

drops, oral administration with 240 mL water

Group Type EXPERIMENTAL

Hyoscine butylbromide

Intervention Type DRUG

drops for oral administration

2 Hyoscine butylbromide

sugar coated tablets, oral administration with 240 mL water

Group Type EXPERIMENTAL

Hyoscine butylbromide

Intervention Type DRUG

sugar coated tablets for oral administration

Interventions

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Hyoscine butylbromide

sugar coated tablets for oral administration

Intervention Type DRUG

Hyoscine butylbromide

drops for oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male and female subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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202.846.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-003720-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

202.846

Identifier Type: -

Identifier Source: org_study_id

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