Overview

Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
The objective was to investigate whether there was a drug-drug interaction between BI 10773 and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773 and glimepiride were determined when both drugs were given in combination compared to multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given alone.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Empagliflozin
Glimepiride
Criteria
Inclusion Criteria:

- Healthy male volunteers according to the following criteria: Based upon a complete
medical history, including the physical examination, vital signs (BP, PR), 12-lead
ECG, clinical laboratory tests

- Age 18 to 50 years (incl.)

- BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)

- Signed and dated written informed consent prior to admission to the study in
accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria:

- Any finding of the medical examination (including BP (Blood Pressure, PR (Pulse Rate)
and ECG (Electrocardiogram)) deviating from normal and of clinical relevance

- Any evidence of a clinically relevant concomitant disease

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders

- Surgery of the gastrointestinal tract (except appendectomy)

- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
neurological disorders

- History of relevant orthostatic hypotension, fainting spells or blackouts

- Chronic or relevant acute infections

- History of relevant allergy/hypersensitivity (including allergy to drug or its
excipients)

- Intake of drugs with a long half-life (> 24 hours) within at least one month or less
than 10 half-lives of the respective drug prior to administration or during the trial

- Participation in another trial with an investigational drug within two months prior to
administration or during the trial

- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

- Inability to refrain from smoking on trial days

- Alcohol abuse (more than 30 g/day)

- Drug abuse

- Blood donation (more than 100 mL within four weeks prior to administration or during
the trial)

- Excessive physical activities (within one week prior to administration or during the
trial)

- Any laboratory value outside the reference range that is of clinical relevance

- Inability to comply with dietary regimen of trial site

- Glucose-6-phosphate dehydrogenase deficiency