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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 187004; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02109679

1307.7

2013-004628-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Treatment A

Experimental group

Description:

multiple doses BI 187004

Treatment:

Drug: BI 187004

Drug: BI 187004

Treatment B

Experimental group

Description:

multiple doses BI 187004 + multiple doses metformin

Treatment:

Drug: metformin

Drug: metformin

Drug: BI 187004

Drug: BI 187004

Treatment C

Experimental group

Description:

multiple doses metformin

Treatment:

Drug: metformin

Drug: metformin