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Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid

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ClinicalTrials.gov Identifier: NCT01634100
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.

Condition or disease Intervention/treatment Phase
Healthy Drug: Probenecid Drug: Rifampicin Drug: Empagliflozin Drug: Empagliflozin (BI 10773) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open-label, Three-way Crossover Trial to Investigate the Effect of Rifampicin and Probenecid on Empagliflozin Pharmacokinetics in Healthy Male and Female Subjects
Study Start Date : June 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A (Reference)
Empagliflozin (BI 10773), Film-coated tablet, single dose
Drug: Probenecid
Probenecid

Drug: Empagliflozin
BI Drug

Drug: Rifampicin
Rifampicin

Experimental: B (Test 1)
Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose
Drug: Rifampicin
Rifampicin

Drug: Empagliflozin
BI Drug

Experimental: C (Test 2)
Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily
Drug: Probenecid
Probenecid

Drug: Empagliflozin (BI 10773)
BI Drug




Primary Outcome Measures :
  1. Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose ]
    Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

  2. Total Empa: Maximum Measured Concentration (Cmax) [ Time Frame: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose ]
    Maximum measured concentration of total empa in plasma, per period.


Secondary Outcome Measures :
  1. Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose ]
    Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634100


Locations
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Germany
1245.83.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01634100     History of Changes
Other Study ID Numbers: 1245.83
2012-000971-17 ( EudraCT Number: EudraCT )
First Posted: July 6, 2012    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Empagliflozin
Rifampin
Probenecid
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents