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Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01734902
First received: November 23, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.


Condition Intervention Phase
Healthy
 Drug: Hyoscine butylbromide
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Hyoscine butylbromide
drops, oral administration with 240 mL water
 Drug: Hyoscine butylbromide
drops for oral administration
Experimental: 2 Hyoscine butylbromide
sugar coated tablets, oral administration with 240 mL water
 Drug: Hyoscine butylbromide
sugar coated tablets for oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734902

Locations
Germany
202.846.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01734902     History of Changes
Other Study ID Numbers: 202.846, 2012-003720-20
Study First Received: November 23, 2012
Last Updated: May 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Butylscopolammonium Bromide
Scopolamine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013