Bioavailability of a Fixed Dose Combination Tablet With BI 10773 and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: A: BI 10773 / metformin tablet (Drug); B: BI 10773 tablet and metformin tablet (Drug); C: BI 10773 / metformin tablet (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

Official title: Relative Bioavailability of a 12.5 mg BI 10773 / 1000 mg Metformin Fixed Dose Combination Tablet Compared With Its Monocomponents and Administered With and Without Food (an Open-label, Randomised, Single-dose, Three-way Crossover, Phase I Trial in Healthy Volunteers)

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AUC of BI 10773 and metformin in plasma over the time interval from 0 hours extrapolated to infinity

Cmax of BI 10773 and metformin in plasma over the time interval from 0 hours extrapolated to infinity

Secondary outcome:

Safety and tolerability endpoints: incidence and intensity of adverse events, assessment of tolerability by the investigator, changes in physical examination, vital signs, ECG, clinical laboratory tests

AUC of BI 10773 and metformin over the time interval from 0 to the last quantifiable data point, time from dosing to the maximum concentration of BI 10773 and metformin in plasma, additional PK parameters as appropriate

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Healthy males and females according to the following criteria

2. Body Mass Index 18. 5 to 29. 9 kg/m2 (incl.)

Exclusion Criteria:

1. Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

1276.5.1 Boehringer Ingelheim Investigational Site, Biberach, Germany; Recruiting

Starting date: September 2010
Last updated: September 29, 2010