Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: hyoscine butylbromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02516098

202.850

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

History of hypersensitivity or allergy to IMP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Hyoscine butylbromide SCT

Active Comparator group

Treatment:

Drug: hyoscine butylbromide

Hyoscine butylbromide

Experimental group

Treatment:

Drug: hyoscine butylbromide