Relative Bioavailability of BI 10773 Administered Twice Daily Compared BI 10773 Given Once Daily After Multiple Oral Doses in Healthy Male and Female Volunteers

NCT02782624 | Completed Phase 1

• 2 other identifiers: 1276.92009-012524-90
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered orally

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 (11)

• 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.

  up to 168 hours

• Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773

  up to 168 hours

• Cavg (average concentration of the analyte in plasma at steady state) of BI 10773

  up to 168 hours

• ¿z,ss (terminal half-life of the analyte in plasma at steady state) of BI 10773

  up to 168 hours

Study Arms (2)

Treatment A: Empagliflozin

EXPERIMENTAL

5 mg bid

Drug: Empagliflozin

Treatment B: Empagliflozin

EXPERIMENTAL

10 mg qd

Drug: Empagliflozin

Interventions

Empagliflozin DRUG

5 days of treatment with 5 mg BI 10773 bid until steady state

Treatment A: Empagliflozin

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1276.9.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

empagliflozin

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 25, 2016
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

DE (1)