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Experience of MTZ Clinical Research in Bioequivalence studies

Lp. Therapeutic /Chemical subgroup Chemical substance Population

Alimentary tract and metabolism

1 Drugs used in diabetes Glimepiride Healthy subjects

2 Lipid modifying agents Lovastatin Healthy subjects

3 Lipid modifying agents Rosuvastatin Healthy subjects

4 Lipid modifying agents Rosuvastatin Healthy subjects

5 Lipid modifying agents Simvastatin Healthy subjects

Antiinfectives for systemic use

6 Antibacterials for systemic use Azithromycin Healthy subjects

7 Antibacterials for systemic use Azithromycin Healthy subjects

8 Antibacterials for systemic use Azithromycin Healthy subjects

9 Antivirals for systemic use Oseltamivir Healthy subjects

10 Antivirals for systemic use Aciclovir Healthy subjects

Antineoplastic and immunomodulating agents

11 Antineoplastic agents Capecitabine Healthy subjects

12 Antineoplastic agents Capecitabine

Metastatic Solid Tumors

13 Antineoplastic agents Capecitabine

Metastatic Solid

Tumors

14 Antineoplastic agents Capecitabine Healthy subjects

15 Antineoplastic agents Capecitabine Healthy subjects

16

Antineoplastic agents

Doxorubicin Hydrochloride

Liposome

Advanced Carcinoma

of the Ovary

17 Taxane Paclitaxel

Metastatic breast cancer

Blood and blood forming organs

18 Antithrombotic agents Acetylsalicylic Acid Healthy subjects

Cardiovascular system

19 Agents acting on the renin-angiotensin system Lisinopril Healthy subjects

20 Agents acting on the renin-angiotensin system Lisinopril Healthy subjects

21 Agents acting on the renin-angiotensin system Lisinopril Healthy subjects

22 Calcium channel blockers Nitrendypine Healthy subjects

23

Calcium channel blockers

Nicardipine

hydrochloride Healthy subjects

24 Cardiac therapy

Isosorbide-5-mononitrate Healthy subjects

25 Cardiac therapy

Isosorbide-5-mononitrate Healthy subjects

26

Cardiac therapy

Isosorbide-5-

mononitrate Healthy subjects

27 Diuretics Indapamide Healthy subjects

28 Diuretics Indapamide Healthy subjects

29 Lipid modifying agents Simvastatin Healthy subjects

30 Vasoprotectives Calcium dobesilate Healthy subjects

Experience of MTZ Clinical Research Early Clinical Development

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Date of issue: May 2019

Lp. Therapeutic /Chemical subgroup Chemical substance Population

Dermatologicals

31 Antipsoriatics Tacalcitol Plaque Psoriasis

32 Antipsoriatics Tacalcitol Plaque Psoriasis

33 Corticosteroids Mometasone furoate Healthy subjects

34 Corticosteroids Mometasone furoate Healthy subjects

35 Corticosteroids Mometasone furoate Healthy subjects

36 Corticosteroids Mometasone furoate Healthy subjects

37

Corticosteroids

Betamethasone

dipropionate

Healthy subjects

38

Corticosteroids

Betamethasone dipropionate and

salicylic acid

Healthy subjects

39

Corticosteroids

Betamethasone dipropionate and

salicylic acid

Healthy subjects

40

Corticosteroids

Betamethasone

dipropionate and

gentamicin sulfate

Healthy subjects

41

Corticosteroids

Betamethasone

dipropionate and

gentamicin sulfate

Healthy subjects

42 Flavonoid Genistein Healthy subjects

Genito-urinary system and sex hormones

43 Sex hormones and modulators of the genital system Megestrol Healthy subjects

44 Sex hormones and modulators of the genital

system Megestrol Healthy subjects

Musculo-skeletal system

45 Antiinflammatory and antirheumatic products Ibuprofen Healthy subjects

46 Antiinflammatory and antirheumatic products Ibuprofen Healthy subjects

47 Antiinflammatory and antirheumatic products Ibuprofen Healthy subjects

48 Anti-inflammatory and antirheumatic products Ibuprofen Healthy subjects

49 Antiinflammatory and antirheumatic products Naproxen Healthy subjects

50 Drugs for treatment of bone diseases Alendronic acid Healthy subjects

51 Drugs for treatment of bone diseases Risedronic acid Healthy subjects

52 Muscle relaxants Thiocolchicoside Healthy subjects

Nervous system

53 Antiepileptics Lamotrigine Healthy subjects

54 Antiepileptics Pregabalin Healthy subjects

55 Antiepileptics Topiramate Healthy subjects

56 Antiepileptics Topiramate Healthy subjects

57

Antivertigo preparations

Cinnarazinum &

Dimenhydrinatum Healthy subjects

58 Other nervous system drugs Betahistine Healthy subjects

59 Psychoanaleptics Amitriptyline Healthy subjects

60 Psychoanaleptics Amitriptyline Healthy subjects

61 Psychoanaleptics Aniracetam Healthy subjects

62 Psychoanaleptics Memantine Healthy subjects

63 Psychoanaleptics Mirtazapine Healthy subjects

64 Psychoanaleptics Rasagiline Healthy subjects

Experience of MTZ Clinical Research Early Clinical Development

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Date of issue: May 2019

Lp. Therapeutic /Chemical subgroup Chemical substance Population

65 Psychoanaleptics Trazodone Healthy subjects

66 Psycholeptics Olanzapine Healthy subjects

Respiratory system

67 Antihistamines Clemastine Healthy subjects

68 Antihistamines Levocetirizine Healthy subjects

69 Antihistamines Loratadine Healthy subjects

70 Drugs for obstructive airway diseases

Fluticasone propionate / salmeterol Healthy subjects

71 Drugs for obstructive airway diseases Mometasone furoate Healthy subjects

72 Drugs for obstructive airway diseases Mometasone furoate Healthy subjects

73 Nasal preparations Fluticasone furoate Healthy subjects

Various

74 Antiinflammatory / Sympathomimetics

Ibuprofen /

Pseudoephedrine

Healthy subjects

75 Antiinflammatory / Sympathomimetics

Ibuprofen / Pseudoephedrine

Healthy subjects