Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

Healthy Clinical Trial

Official title:

A Single Center, Single-dose, Double-blind, Randomized, Two Period Crossover, Two Stage Design to Determine Bioequivalence of Two Formulations Containing Hyoscine Butylbromide 10mg Sugar Coated Tablets, Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516098
• Other study ID #: 202.850
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2015
• Last updated: March 7, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

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

Exclusion criteria:

History of hypersensitivity or allergy to IMP

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• hyoscine butylbromide

Locations

Country	Name	City	State
Canada	Parexel Bloemfontein	Bloemfontein

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration cmax		2 days	No
Primary	AUC time zero to times of last quantifiable concentration (AUC o-t)		2 days	No
Secondary	Area under the plasma concentration versus time curve, with extrapolation to infinity		2 days	No
Secondary	Area under the curve, for the test product, to the time of the maximum concentration of the reference product		2 days	No