Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers
NCT ID: NCT02172235
Last Updated: 2014-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2010-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers
NCT02276365
Bioavailability of BI 1356 With and Without Co-administration of Pioglitazone and the Bioavailability of Pioglitazone With and Without Coadministration of BI 1356 in Healthy Male and Female Volunteers
NCT02183337
Relative Bioavailability BI 10773 and Metformin in Healthy Male Volunteers
NCT02172248
Bioavailability of BI 10773 and Sitagliptin in Healthy Male Volunteers
NCT02172196
Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers
NCT02172222
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pioglitazone
Pioglitazone
Pioglitazone + BI 10773 low
Pioglitazone
BI 10773 - low dose
Pioglitazone + BI 10773 medium
Pioglitazone
BI 10773 - medium dose
Pioglitazone + BI 10773 high
Pioglitazone
BI 10773 - high dose
Pioglitazone low + BI 10773 medium
Pioglitazone - low dose
BI 10773 - medium dose
Pioglitazone + BI 10773 1 hour after Pioglitazone
Pioglitazone
BI 10773 - medium dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pioglitazone
Pioglitazone - low dose
BI 10773 - low dose
BI 10773 - medium dose
BI 10773 - high dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
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
18 Years
55 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1245.50
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.