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

NCT01211197 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-08-21

Study results available
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Summary

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

C: BI 10773 / metformin tablet

BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal

DRUG

B: BI 10773 tablet and metformin tablet

BI 10773 and metformin single tablets, administered together in fasted state

DRUG

A: BI 10773 / metformin tablet

BI 10773 / metformin fixed dose combination tablet in fasted state

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211197 on ClinicalTrials.gov