Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers

NCT02172261 | Completed Phase 1

• 1 other identifier: 1245.7
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773

  up to 5 days

• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773

  up to 5 days

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of glimepiride

  up to 4 days

• Cmax (maximum measured concentration of the analyte in plasma) of glimepiride

  up to 4 days

Secondary Outcomes (27)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) of glimepiride

  up to 4 days

• tmax (time from dosing to the maximum concentration of the analyte in plasma) of glimepiride

  up to 4 days

• λz (terminal rate constant in plasma) of glimepiride

  up to 4 days

• t½ (terminal half-life of the analyte in plasma) of glimepiride

  up to 4 days

• MRTpo (mean residence time of the analyte in the body after po administration) of glimepiride

  up to 4 days

Study Arms (2)

Sequence ABC

EXPERIMENTAL

1. Treatment A: BI 10773 once daily from day 1 to 5 2. Treatment B: BI 10773 and glimepiride once on day 1 3. Treatment C: Glimepiride once on day 1

Drug: BI 10773; Drug: Glimepiride

Sequence CAB

EXPERIMENTAL

1. Treatment C: Glimepiride once on day 1 2. Treatment A: BI 10773 once daily from day 1 to 5 3. Treatment B: BI 10773 and glimepiride once on day 1

Drug: BI 10773; Drug: Glimepiride

Interventions

BI 10773 DRUG

Sequence ABC; Sequence CAB

Glimepiride DRUG

Sequence ABC; Sequence CAB

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

empagliflozin; glimepiride

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06