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Completed

NCT Number: NCT02516098

Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boehringer Ingelheim Investigational Site

Bloemfontein, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

History of hypersensitivity or allergy to IMP

Treatment and study plan

Hyoscine Butylbromide

Drug

Primary outcomes

  1. Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)

    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

    The maximum measured concentration of hyoscine butylbromide in plasma.

  2. AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-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

    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 outcomes

  1. Area Under the Plasma Concentration Versus Time Curve, With Extrapolation 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

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

  2. Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)

    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 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2015
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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