Fázis I vizsgálatok

DRC Phase I Unit
Therapeutic Area Type of Study Number of Volunteers
1. hormon replacement PK study/Renal impairment patients 24  patients with renal insufficiency
2. potassium replacement Bioequivalence 24 HV
3. respiratory disease Bioequivalence 28 HV
4. psychiatry Method validation for interaction studies 18 HV
5. neurology Bioequivalence 24 HV
6. neurology Bioequivalence 24 HV
7. neurology Bioequivalence 24 HV
8. cardiovascular disease Bioequivalence 24 HV
9. antidepressant/ alcohol Interaction study 24HV
10. gastroenterology Bioequivalence / food interaction 24HV
11. gastroenterology Bioequivalence 32 HV
12. cardiovascular disease Bioequivalence 36 HV
13. Type 2 Diabetes Bioequivalence 24HV
14. anxiolitic/anxiolitic Interaction study 16 HV
15. cardiovascular disease Bioequivalence / food interaction 32 HV
16. cardiovascular disease pharmacokinetic in elderly population 24 HV, elderly healthy volunteers
17. cardiovascular disease Bioequivalence / food interaction 32 HV
18. neurology Hepatic impairment study 16 hepatic patients
19. rheumatology Bioequivalence 28 HV
20. respiratory disease PK study/Hepatic patients 24 hepatic patients
21. Type 2 Diabetes Multiple dose; dose ranging study 36 HV
22. oral contraceptive Bioequivalence 41 HV female
23. gastroenterology Bioequivalence 32 HV
24. gastroenterology Bioequivalence 32 HV
25. allergic disorders Pharmacokinetic, pharmacodynamic study 8 HV
26. gastroenterology Multiple dose; dose ranging stduy 60 HV
27. liver function diagnostic PK study, single i.v. dose 12 HV
28. rheumatology Pharmacokinetic study 11 hepatic patients, 12HV
29. musculosceletal Interaction study 16 HV
30. allergic disorders Pharmacodinamic Study 20 HV
31. allergic disorders Bioequivalence study 28 HV
32. infection disease Hepatic impairment study 32 hepatic patients, 16 HV
33. rheumatology Dose ranging study 5 RA patients
34. Insulin sensitizer / olanzapine Interaction study 54 HV
35. gastroenterology Multiple dose; dose ranging study 12 HV
36. T2 diabetes mellitus Multiple dose; dose ranging study 10 type II Diabetes patients
37. cardiovascular disease Pharmacokinetic study 19 patients with renal insufficiency
38. urology Ascending single dose study 37 HV
39. rheumatology Interaction study 4 RA patients
40. liver function diagnostic PK study, multiple dose i.v. (different volume) 24 HV
41. rheumatology Ascending, multiple dose study 5 RA patients
42. liver function diagnostic PK cross-over study-i.v. 12 HV
43. allergic disorders Dose ranging, multiple dose 60 allergic volunteers
44. urogenital disorder ascending multiple dose 24 HV
45. respiratory disease Renal impairment study 12 patients with renal insufficiency + 12 HV (group matching)
46. musculosceletal disorder Bioequivalence 52 HV
47. Sleep disorder Liver impairment study 13 hepatic patients + 13 HV (pair matching)
48. Type 2 Diabetes single ascending dose 11 diabetic patients
49. liver function diagnostic / Carbamazepine Interaction study 36 HV
50. Type 2 Diabetes PK study / single dose 18 patients with renal insufficiency + 4 HV (group matching)
51. musculosceletal disorder Bioequivalence 52 HV
52. urogenital disorder Multiple ascending dose 32 HV
53. liver function diagnostic PK study for comparison and validation of different methods 32 HV
54. Vaccines Single ascending dose 22 HV adults, 88 eldery HV
55. Type 2 Diabetes PK study/Renal impairment 23 renal patients
56. Diabetic nephropathy PK study/Renal impairment 18 renal patients, 14 HV
57. rheumatology Exploratory study for kinetics for cholesterol flux 5 RA patients, 5 HV
58. neurology PK study/Liver impairment 17 hepatic patients, 17 HV
59. psychiatry PK study/Liver impairment 7 hepatic patients, 4 HV
60. gastroenterology PK study/Liver impairment 13 hepatic patients, 7 HV
61. immunmodulator PK study/Liver impairment 24 hepatic patients, 8 HV
62. dermatology Multiple ascending dose 5 acne vulgaris patients
63. antiviral medication PK study/Liver impairment 7 hepatic patients, 8 HV
64. neurology PK study/Liver impairment 10 hepatic patients, 11 HV
65. immunmodulator PK study/Renal impairment 16 renal patients, 8 HV
66. Type 2 Diabetes PK Study/Liver impairment 13 hepatic patients, 5 HV
67. Vaccines Multiple dose study 140 HV
68. Gastroenterology Multiple ascending dose 6 UC patients
69. Dermatology Multiple ascending dose 6 Psoriatic patients
70. Rheumatology Multiple ascending dose 3 RA patients
71. Rheumatology Multiple ascending dose 3 RA patients
72. Gastroenterology Single Ascending dose 3 UC patients
73. Vitamin suplementation PK study / single dose 26 Vitamin D deficient adults
74. Alzheimer’s disease PK study / single ascending dose 20 HV
Note: HV= Healthy Volunteers
Clamp Studies on Healthy and Diabetic Patients
Year Type of Study Completed Clamps
2005 Phase II. 84
2008 Interaction study 108
2010 Scientific 100
2011 Scientific 60
Total number of completed clamps 352