Skip to main content
OpenTrials
Completed

NCT Number: NCT02172235

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Age 18 to 55 years (incl.)
  • BMI 18.5 to 29.9 kg/m2 (incl.)
  • 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

  • Any finding of the medical examination including blood pressure (BP), pulse rate (PR) and electrocardiogram (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
  • 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 (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
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (more than 10 cigarettes or more than 3 cigars or more than 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)
  • Alanine aminotransferase (ALT) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • Galactose or lactose intolerance, galactose or glucose malabsorption

Treatment and study plan

pioglitazone

Drug

Pioglitazone - low dose

Drug

BI 10773 - low dose

Drug

BI 10773 - medium dose

Drug

BI 10773 - high dose

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.