ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 186 for:    BI10773

Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02172261
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 10773 Drug: Glimepiride Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Both BI 10773 and Glimepiride After Co-administration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and a Single Dose of Glimepiride (1 mg) Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
Study Start Date : April 2009
Actual Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence ABC
  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
Experimental: Sequence CAB
  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



Primary Outcome Measures :
  1. 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 [ Time Frame: up to 5 days ]
  2. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773 [ Time Frame: up to 5 days ]
  3. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of glimepiride [ Time Frame: up to 4 days ]
  4. Cmax (maximum measured concentration of the analyte in plasma) of glimepiride [ Time Frame: up to 4 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: up to 4 days ]
  2. tmax (time from dosing to the maximum concentration of the analyte in plasma) of glimepiride [ Time Frame: up to 4 days ]
  3. λz (terminal rate constant in plasma) of glimepiride [ Time Frame: up to 4 days ]
  4. t½ (terminal half-life of the analyte in plasma) of glimepiride [ Time Frame: up to 4 days ]
  5. MRTpo (mean residence time of the analyte in the body after po administration) of glimepiride [ Time Frame: up to 4 days ]
  6. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) of glimepiride [ Time Frame: up to 4 days ]
  7. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of glimepiride [ Time Frame: up to 4 days ]
  8. tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773 [ Time Frame: up to 5 days ]
  9. Aet1-t2 (amount of analyte eliminated in urine over the time interval from t1 to t2) of glimepiride [ Time Frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 ]
  10. fet1-t2 (fraction of analyte excreted unchanged in urine over the time interval from t1 to t2) of glimepiride [ Time Frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 ]
  11. CLR (renal clearance of the analyte) of glimepiride [ Time Frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 ]
  12. λz,ss (terminal rate constant of analyte in plasma at steady-state) of BI 10773 [ Time Frame: up to 5 days ]
  13. t½,ss (terminal half-life of analyte in plasma at steady-state) of BI 10773 [ Time Frame: up to 5 days ]
  14. MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773 [ Time Frame: up to 5 days ]
  15. CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773 [ Time Frame: up to 5 days ]
  16. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 10773 [ Time Frame: up to 5 days ]
  17. Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ) of BI 10773 [ Time Frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5 ]
  18. fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ) of BI 10773 [ Time Frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5 ]
  19. CLR,ss (renal clearance of the analyte at steady state) of BI 10773 [ Time Frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5 ]
  20. UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h) [ Time Frame: 1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on days 1 and 5 ]
  21. Number of patients with abnormal findings in physical examination [ Time Frame: Baseline and within 3-14 days after last glimepiride administration ]
  22. Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate) [ Time Frame: Baseline, day 1 and within 3-14 days after last glimepiride administration ]
  23. Number of patients with abnormal findings in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline, day 1 and within 3-14 days after last glimepiride administration ]
  24. Number of patients with abnormal findings in clinical laboratory tests [ Time Frame: Baseline, day 1,4 and within 3-14 days after last glimepiride administration ]
  25. Number of patients with adverse events [ Time Frame: Up to 34 days ]
  26. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Within 3-14 days after last glimepiride administration ]
  27. Number of patients with abnormal findings in glucose bedside tests [ Time Frame: Pre-dose and 1, 2, 4, 7, 10, 14, 24 hours after glimepiride administration on day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172261     History of Changes
Other Study ID Numbers: 1245.7
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Glimepiride
Empagliflozin
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors