Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: hyoscine butylbromide

• Registration Number: NCT02516098
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-05
• Study Start: 2015-10
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-12-20
• Results First Submitted QC: 2016-12-20
• Results First Posted: 2017-02-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hyoscine butylbromide	hyoscine butylbromide	-
Hyoscine butylbromide SCT	hyoscine butylbromide	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)	Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter	The maximum measured concentration of hyoscine butylbromide in plasma.
AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)	Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter	Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)	Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter	Area under the concentration-time curve of hyoscine butylbromide to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®). This was calculated both for test and reference products.
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).	Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter	The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇨🇦 Bloemfontein, Canada