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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Hyoscine butylbromide

• Registration Number: NCT01734902
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-01
• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-28
• Primary Completion: 2012-12-01
• Study Completion: 2012-12-01
• Results First Submitted: 2018-12-20
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-22
• Last Update Submitted: 2019-04-22
• Results First Posted: 2019-04-23
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 Hyoscine butylbromide	Hyoscine butylbromide	drops, oral administration with 240 mL water
2 Hyoscine butylbromide	Hyoscine butylbromide	sugar coated tablets, oral administration with 240 mL water

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)	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.	Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.
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)	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.	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

Secondary Outcome Measures

Name	Time	Method
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.	AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity

Trial Locations

Locations (1)

202.846.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany