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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets

NCT01924767 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-07-04

Study results available
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Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 10773 Placebo

po taken fasting with 240 mL water

DRUG

BI 10773

po taken fasting with 240 mL water

DRUG

BI 10773 Placebo

po taken fasting with 240 mL water

DRUG

BI 10773

po taken fasting with 240 mL water

DRUG

BI 10773 Placebo

po taken fasting with 240 mL water

DRUG

BI 10773 Placebo

po taken fasting with 240 mL water

DRUG

BI 10773

po taken fasting with 240 mL water

DRUG

BI 10773

po taken fasting with 240 mL water

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Germany

Study Locations

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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 NCT01924767 on ClinicalTrials.gov