Relative Bioavailability of BI 10773 Administered Twice D... | NCT02782624

ID	Type	Description	Link
2009-012524-90	EudraCT Number	EudraCT

Status Module

Label	Type	Description	Intervention Names
Treatment A: Empagliflozin	Experimental	5 mg bid	Drug: Empagliflozin
Treatment B: Empagliflozin	Experimental	10 mg qd	Drug: Empagliflozin

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin	Drug	5 days of treatment with 5 mg BI 10773 bid until steady state	Treatment A: Empagliflozin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC (area under the concentration-time curve of the analyte in plasma) - AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for 10 mg BI 10773 QD.		up to 168 hours
AUC (area under the concentration-time curve of the analyte in plasma) - AUC0-24,ss (area under the concentration-time curves of the analyte in plasma at steady-state over two dosing intervals) for 5 mg BI 10773 BID after the morning dose on Day 5.		up to 168 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.		up to 168 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.		up to 168 hours

Secondary Outcomes

Measure	Description	Time Frame
C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose for the BID regimen) of BI 10773.		up to 168 hours
C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose for the QD regimen) of BI 10773.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Healthy males and females 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 and Age = 50 years
BMI = 18.5 and = 29.9 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria:

Any finding of the medical examination (including BP, PR and ECG) 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 6. 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 within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
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 (average consumption of more than 20 g/day in females and 30 g/day in males)
Drug abuse
Blood donation (more than 100 mL within four weeks prior to the start of study)
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
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

For female subjects:

Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 1 month after study completion
No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD A record of all subjects screened, in- or excluded, will be maintained. (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
Lactation