NCT02516098

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 13, 2017

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

August 3, 2015

Results QC Date

December 20, 2016

Last Update Submit

March 7, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)

    The maximum measured concentration of hyoscine butylbromide in plasma.

    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).

    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 (2)

  • 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

  • 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

Study Arms (2)

Hyoscine butylbromide SCT

ACTIVE COMPARATOR
Drug: hyoscine butylbromide

Hyoscine butylbromide

EXPERIMENTAL
Drug: hyoscine butylbromide

Interventions

hyoscine butylbromideDRUG
Hyoscine butylbromideHyoscine butylbromide SCT

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • History of hypersensitivity or allergy to IMP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim Investigational Site

Bloemfontein, Canada

Location

MeSH Terms

Interventions

Butylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Limitations and Caveats

There was a stage 2 planned after stage 1 which was not performed as bioequivalence was concluded after completion of Stage 1.

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 5, 2017

Results First Posted

February 13, 2017

Record last verified: 2017-03

Locations

CA(1)