healthy
Conditions
Interventions
Trade Name: Avandia
Product Name: Avandia
Product Code: EU/1/00/137/001
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade
Sponsors
Clinical Pharmacology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - male nonsmokers - age: 18 to 35 years - Body mass index between 15th and 85th percentile - Normal findings in medical history, physical and laboratory examinations including OGTT unless the investigator considers an abnormality to be clinically irrelevant - written informed consent - Normal ophthalmic findings, ametropy =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceeding the study - Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia - Treatment in the previous 3 weeks with any drug - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs - Blood donation during the previous 3 weeks - History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of rosiglitazone on FFA induced endothelial dysfunction in response to locally applied acetylcholine and nitroglycerine as well as on ocular hemodynamics and on insulin resistance measured by a short insulin tolerance test in healthy volunteers.;Secondary Objective: ;Primary end point(s): - Forearm blood flow - Retinal vessels diameter (retinal vessel analyser) - Choroidal blood flow (laser interferometry) | — |
Countries
Austria
Outcome results
None listed