Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
2 other identifiers
interventional
30
1 country
1
Brief Summary
The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Nov 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 23, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
April 23, 2019
CompletedApril 23, 2019
April 1, 2019
1 month
November 23, 2012
December 20, 2018
April 22, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)
Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.
Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point
Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
Secondary Outcomes (1)
Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )
Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
Study Arms (2)
1 Hyoscine butylbromide
EXPERIMENTALdrops, oral administration with 240 mL water
2 Hyoscine butylbromide
EXPERIMENTALsugar coated tablets, oral administration with 240 mL water
Interventions
Eligibility Criteria
You may qualify if:
- \. Healthy male and female subjects
You may not qualify if:
- \. Any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
202.846.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2012
First Posted
November 28, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
April 23, 2019
Results First Posted
April 23, 2019
Record last verified: 2019-04