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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pioglitazone; Drug: BI 10773 - medium dose; Drug: BI 10773 - high dose; Drug: BI 10773 - low dose; Drug: Pioglitazone - low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02172235

1245.50

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

Pioglitazone

Active Comparator group

Treatment:

Drug: Pioglitazone

Pioglitazone + BI 10773 low

Experimental group

Treatment:

Drug: Pioglitazone

Drug: BI 10773 - low dose

Pioglitazone + BI 10773 medium

Experimental group

Treatment:

Drug: Pioglitazone

Drug: BI 10773 - medium dose

Pioglitazone + BI 10773 high

Experimental group

Treatment:

Drug: BI 10773 - high dose

Drug: Pioglitazone

Pioglitazone low + BI 10773 medium

Experimental group

Treatment:

Drug: BI 10773 - medium dose

Drug: Pioglitazone - low dose

Pioglitazone + BI 10773 1 hour after Pioglitazone

Experimental group

Treatment:

Drug: Pioglitazone

Drug: BI 10773 - medium dose