Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

Phase 1CompletedNCT02516098

Boehringer Ingelheim56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

hyoscine butylbromideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: healthy males and females, aged 18-50years, BMI 18,5-30 Exclusion criteria: History of hypersensitivity or allergy to IMP

Locations (1)

Boehringer Ingelheim Investigational Site

Bloemfontein, Canada

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)

The maximum measured concentration of hyoscine butylbromide in plasma.

Time frame: 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

AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)

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).

Time frame: 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

Secondary Outcomes

Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).

The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Time frame: 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 Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)

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.

Time frame: 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

Data from ClinicalTrials.gov

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