Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

NCT ID: NCT02516098

Last Updated: 2017-04-05

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2015-12-31

Brief Summary

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Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.

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

DOUBLE

Study Groups

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Hyoscine butylbromide SCT

Group Type ACTIVE_COMPARATOR

hyoscine butylbromide

Intervention Type DRUG

Hyoscine butylbromide

Group Type EXPERIMENTAL

hyoscine butylbromide

Intervention Type DRUG

Interventions

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hyoscine butylbromide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

healthy males and females, aged 18-50years, BMI 18,5-30

Exclusion Criteria

History of hypersensitivity or allergy to IMP
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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Boehringer Ingelheim Investigational Site

Bloemfontein, , Canada

Site Status

Countries

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Canada

Other Identifiers

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202.850

Identifier Type: -

Identifier Source: org_study_id

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