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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: pantoprazole 40 mg STADA; Drug: BI 113608 PIB; Drug: BI 113608

• Registration Number: NCT01703858
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-11
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Results First Posted: 2017-01-20
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4 BI 113608	pantoprazole 40 mg STADA	conventional tablet after pantoprazole administration
1 BI 113608	BI 113608 PIB	powder in the bottle for oral solution, oral administration with 240 mL water
2 BI 113608	BI 113608	conventional tablet formulation
3 BI 113608	BI 113608	conventional tablet formulation, fed
4 BI 113608	BI 113608	conventional tablet after pantoprazole administration
5 BI 113608	BI 113608	conventional tablet formulation, fasted, 0:30 min before fat breakfast

Primary Outcome Measures

Name	Time	Method
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)	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)	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

Name	Time	Method
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)	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).

Trial Locations

Locations (1)

1314.3.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany