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