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
ConditionHealthy
InterventionDrug: BI 113608 PIB
Drug: BI 113608
Drug: BI 113608
Drug: BI 113608
Drug: pantoprazole 40 mg STADA
Drug: BI 113608
PhasePhase 1
SponsorBoehringer Ingelheim
Responsible PartyBoehringer Ingelheim
ClinicalTrials.gov IdentifierNCT01703858
First ReceivedOctober 8, 2012
Last UpdatedJuly 10, 2013
Last verifiedJuly 2013

Tracking Information[ + expand ][ + ]

First Received DateOctober 8, 2012
Last Updated DateJuly 10, 2013
Start DateSeptember 2012
Estimated Primary Completion DateJanuary 2013
Current 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 20 weeks] [Designated as safety issue: No]
  • Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 20 weeks] [Designated as safety issue: No]
Current Secondary Outcome MeasuresAUC0-8 (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 TitleStudy to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Official TitleAn 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: 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)
  • Active Comparator: 1 BI 113608
    powder in the bottle for oral solution, oral administration with 240 mL water
  • Experimental: 2 BI 113608
    conventional tablet formulation
  • Experimental: 3 BI 113608
    conventional tablet formulation, fed
  • Experimental: 4 BI 113608
    conventional tablet after pantoprazole administration
  • Experimental: 5 BI 113608
    conventional tablet formulation, fasted, 0:30 min before fat breakfast

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment15
Estimated Completion DateJanuary 2013
Estimated Primary Completion DateJanuary 2013
Eligibility Criteria
Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
GenderMale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesGermany

Administrative Information[ + expand ][ + ]

NCT Number NCT01703858
Other Study ID Numbers1314.3
Has Data Monitoring CommitteeNot Provided
Information Provided ByBoehringer Ingelheim
Study SponsorBoehringer Ingelheim
CollaboratorsNot Provided
Investigators Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Verification DateJuly 2013

Locations[ + expand ][ + ]

1314.3.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany