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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
ClinicalTrials.gov Identifier:
NCT01734902
First received: November 23, 2012
Last updated: June 13, 2013
Last verified: June 2013
  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:


Further study details as provided by Boehringer Ingelheim:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01734902     History of Changes
Other Study ID Numbers: 202.846, 2012-003720-20
Study First Received: November 23, 2012
Last Updated: June 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 20, 2014