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Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01703858
First received: October 8, 2012
Last updated: November 23, 2016
Last verified: November 2016
  Purpose
The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects

Condition Intervention Phase
Healthy
Drug: BI 113608 PIB
Drug: BI 113608
Drug: pantoprazole 40 mg STADA
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration. ]
    Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

  • Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax) [ Time Frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration. ]
    Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).


Secondary Outcome Measures:
  • Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) [ Time Frame: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration. ]
    Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).


Enrollment: 15
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 BI 113608
powder in the bottle for oral solution, oral administration with 240 mL water
Drug: BI 113608 PIB
powder for oral solution
Experimental: 2 BI 113608
conventional tablet formulation
Drug: BI 113608
conventional tablet formulation
Experimental: 3 BI 113608
conventional tablet formulation, fed
Drug: BI 113608
conventional tablet formulation
Experimental: 4 BI 113608
conventional tablet after pantoprazole administration
Drug: pantoprazole 40 mg STADA
film-coated tablet
Drug: BI 113608
conventional tablet formulation
Experimental: 5 BI 113608
conventional tablet formulation, fasted, 0:30 min before fat breakfast
Drug: BI 113608
conventional tablet formulation

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male 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: NCT01703858

Locations
Germany
1314.3.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01703858     History of Changes
Other Study ID Numbers: 1314.3
2012-002537-11 ( EudraCT Number: EudraCT )
Study First Received: October 8, 2012
Results First Received: November 23, 2016
Last Updated: November 23, 2016

Additional relevant MeSH terms:
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017