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 prevention | PK study / single ascending dose | 20 HV |
75. | Seizure | PK study / Single ascending dose | 6 renal patients |
76. | Vaccines | PK/PD Study | 36 HV |
77. | Gastroenterology | PK study | 2 UC patients |
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 | ||
Fázis I vizsgálatok
DRC Kft. 8230 Balatonfüred, Ady Endre utca 12/b. Tel.:+36 87 481 616 Fax: +36 87 580 116 e-mail: drc@drc.hu