Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Hyoscine butylbromide (Drug); Hyoscine butylbromide (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
The objective of the current trial is to establish the bioequivalence of 2 hyoscine
butylbromide dose forms following oral administration.
Clinical Details
Official title: Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide, Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Study)
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)Cmax (maximum measured concentration of the analyte in plasma)
Secondary outcome: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
Locations and Contacts
202.846.1 Boehringer Ingelheim Investigational Site, Ingelheim, Germany
Additional Information
Starting date: November 2012
Last updated: June 13, 2013
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