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Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02172235
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 the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs

Condition or disease Intervention/treatment Phase
Healthy Drug: Pioglitazone Drug: Pioglitazone - low dose Drug: BI 10773 - low dose Drug: BI 10773 - medium dose Drug: BI 10773 - high dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
Study Start Date : April 2010
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pioglitazone Drug: Pioglitazone
Experimental: Pioglitazone + BI 10773 low Drug: Pioglitazone
Drug: BI 10773 - low dose
Experimental: Pioglitazone + BI 10773 medium Drug: Pioglitazone
Drug: BI 10773 - medium dose
Experimental: Pioglitazone + BI 10773 high Drug: Pioglitazone
Drug: BI 10773 - high dose
Experimental: Pioglitazone low + BI 10773 medium Drug: Pioglitazone - low dose
Drug: BI 10773 - medium dose
Experimental: Pioglitazone + BI 10773 1 hour after Pioglitazone Drug: Pioglitazone
Drug: BI 10773 - medium dose



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) [ Time Frame: Before each dosing, up to 10 days ]
  2. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Before each dosing, up to 10 days ]

Secondary Outcome Measures :
  1. C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose) [ Time Frame: Before each dosing, up to 10 days ]
  2. λz (terminal elimination rate constant of the analyte in plasma) [ Time Frame: Before each dosing, up to 10 days ]
  3. t½ (terminal half-life of the analyte in plasma) [ Time Frame: Before each dosing, up to 10 days ]
  4. tmax (time from last dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: Before each dosing, up to 10 days ]
  5. MRTpo (mean residence time of the analyte in the body at steady state after oral administration) [ Time Frame: Before each dosing, up to 10 days ]
  6. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: Before each dosing, up to 10 days ]
  7. Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration) [ Time Frame: Before each dosing, up to 10 days ]
  8. Aet1-t2 (amount of analyte eliminated in urine over the time interval t1 to t2 ) [ Time Frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h) ]
  9. fet1-t2 (fraction of dose excreted unchanged in urine over the time interval t1 to t2) [ Time Frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h) ]
  10. CLR (renal clearance of the analyte in plasma afer extravascular administration) [ Time Frame: Day1 (-1-0, 0-4, 4-8, 8-12, and 12-24 h), Day 7 (143-144, 144-148, 148-152, 152-156, and 156-168 h) ]
  11. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: Before each dosing, up to 10 days ]
  12. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration) [ Time Frame: Before each dosing, up to 10 days ]
  13. AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable plasma concentration within the first dosing interval) [ Time Frame: Before each dosing, up to 10 days ]
  14. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Before each dosing, up to 10 days ]
  15. Metabolite to parent ratio [ Time Frame: Before each dosing, up to 10 days ]
  16. Number of patients with abnormal findings in physical examination [ Time Frame: up to 30 days after drug administration ]
  17. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 30 days after drug administration ]
  18. Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG) [ Time Frame: up to 30 days after drug administration ]
  19. Number of patients with clinically significant changes in vital signs [ Time Frame: up to 30 days after drug administration ]
  20. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 10 days ]
  21. Number of patients with adverse events [ Time Frame: up to 51 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male subjects according to the following criteria:

    medical history, physical examination, vital signs ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)), clinical laboratory tests

  2. Age 18 to 55 years (incl.)
  3. BMI 18.5 to 29.9 kg/m2 (incl.)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practise (GCP) and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. 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.
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
  12. Inability to refrain from smoking on trial days
  13. Alcohol abuse (more than 30 g/day)
  14. Drug abuse
  15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  16. Excessive physical activities (within one week prior to administration or during the trial)
  17. Alanine aminotransferase (ALT) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of trial site
  19. Galactose or lactose intolerance, galactose or glucose malabsorption

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172235     History of Changes
Other Study ID Numbers: 1245.50
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Pioglitazone
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action