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Healthy | Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects

Healthy research study

What is the primary objective of this study?

To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI 187004 and metformin given alone.

Who is eligible to participate?

Inclusion criteria: 1. Healthy male subjects 2. Subjects must be able to understand and comply with study requirements 3. Age of 18 to 50 years 4. Body mass index (BMI) of 18.5 to 29.9 kg/m2 Exclusion criteria: 1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease judged as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair) 7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:metforminmultiple doses metformin given as tablet

Drug:BI 187004multiple doses BI 187004 given as tablets

Drug:BI 187004multiple doses BI 187004 given as tablets

Drug:metforminmultiple doses metformin given as tablet

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Treatment Amultiple doses BI 187004

Treatment Bmultiple doses BI 187004 + multiple doses metformin

Treatment Cmultiple doses metformin

Study Status

Completed

Start Date: May 2014

Completed Date: July 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Boehringer Ingelheim

Lead Sponsor: Boehringer Ingelheim

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02109679

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