Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Overview[ - collapse ][ - ]
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 |
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Condition | Healthy |
Intervention | Drug: BI 113608 PIB Drug: BI 113608 Drug: BI 113608 Drug: BI 113608 Drug: pantoprazole 40 mg STADA Drug: BI 113608 |
Phase | Phase 1 |
Sponsor | Boehringer Ingelheim |
Responsible Party | Boehringer Ingelheim |
ClinicalTrials.gov Identifier | NCT01703858 |
First Received | October 8, 2012 |
Last Updated | July 10, 2013 |
Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 8, 2012 |
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Last Updated Date | July 10, 2013 |
Start Date | September 2012 |
Estimated Primary Completion Date | January 2013 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Time Frame: up to 20 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608 |
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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 |
Brief Summary | 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 |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Healthy |
Intervention | Drug: BI 113608 PIB powder for oral solution Drug: BI 113608 conventional tablet formulation Drug: BI 113608 conventional tablet formulation Drug: BI 113608 conventional tablet formulation Drug: pantoprazole 40 mg STADA film-coated tablet Drug: BI 113608 conventional tablet formulation |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 15 |
Estimated Completion Date | January 2013 |
Estimated Primary Completion Date | January 2013 |
Eligibility Criteria | Inclusion criteria: 1. healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions |
Gender | Male |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Germany |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01703858 |
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Other Study ID Numbers | 1314.3 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Boehringer Ingelheim |
Study Sponsor | Boehringer Ingelheim |
Collaborators | Not Provided |
Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
Verification Date | July 2013 |
Locations[ + expand ][ + ]
1314.3.1 Boehringer Ingelheim Investigational Site | Ingelheim, Germany |
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