Všetky ochorenia 1. Acne 1. Acne vulgaris 1. Acute myeloid leukemia, 2. Leukaemias acute myeloid, 3. Neoplasms benign, malignant and unspecified (incl cysts and polyps), 4. Leukaemias, 5. Acute myeloid leukaemia 1. Acute myocardial infarction 1. Acute pain 1. Acute pancreatitis 1. Advanced breast cancer 1. Advanced cancer, 2. Leukaemias 1. Age-related macular degeneration 1. Alkaptonuria 1. Allergic conjunctivitis 1. Allergic rhinitis due to other allergen 1. Allergic rhinitis due to pollen 1. Allergic rhinoconjunctivitis, 2. Allergic rhinitis (excl hay fever) 1. Alzheimer's disease 1. Alzheimer's disease, 2. Nervous system disorders 1. Amyotrophic lateral sclerosis 1. Anemia 1. Angiofibroma, 2. Juvenile angiofibroma 1. Ankylosing spondylitis 1. Arteriosclerotic cardiovascular disease, 2. Atherosclerotic cardiovascular disease 1. Asthma 1. Asthma-COPD overlap syndrome 1. Asthma, 2. Asthma bronchial, 3. Eosinophilic asthma 1. Asthma, unspecified 1. Atherosclerosis 1. Atopic dermatitis 1. Atrial fibrillation 1. Atrial fibrillation, 2. Acute coronary syndrome, 3. Percutaneous coronary intervention 1. Atrial fibrillation, 2. Percutaneous coronary intervention 1. Attack coronary, 2. Acute coronary syndrome, 3. Non ST segment elevation acute coronary syndrome, 4. ST segment elevation 1. Autism spectrum disorder 1. Bipolar depression 1. Birch pollen allergy 1. Bladder cancer stage I, with cancer in situ 1. Breast cancer 1. Breast cancer NOS stage I 1. Bronchiectasis 1. Cancer pain 1. Cardiogenic shock, 2. Acute myocardial infarction 1. Cardiovascular disease, unspecified 1. Cerebellar embolism, 2. Embolic stroke, 3. Embolic cerebral infarction, 4. Brain stem embolism 1. Cervical cancer stage IV, 2. Cervical cancer recurrent 1. Clostridium difficile infection 1. Colitis (excl infective) 1. Colitis ulcerative acute episode 1. Colon cancer stage IV, 2. Colon cancer metastatic, 3. Colorectal cancer stage IV, 4. Colorectal cancer metastatic 1. Colorectal cancer metastatic 1. Community acquired pneumonia 1. Complex regional pain syndrome Type I, 2. Complex regional pain syndrome Type II 1. COPD 1. Crohn's disease 1. Crohn's disease, 2. Ulcerative colitis 1. Crohnova choroba, 2. Ulcerózna kolitída 1. Cystic fibrosis 1. Cystic fibrosis NOS 1. Dementia Alzheimer's type, 2. Alzheimer's disease, 3. Prodromal Alzheimer's disease 1. Dementia of the Alzheimer's type, with delusions, 2. Hallucinations 1. Dementia of the Alzheimer's type, with depressed mood 1. Detrusor hyperreflexia, 2. Overactive bladder 1. Diabetes mellitus (incl subtypes) 1. Diabetic macular edema 1. Diabetic macular edema, 2. Eye disorders 1. Diabetic macular oedema, 2. Diabetic macular edema 1. Diabetic nephropathy 1. Diabetic peripheral neuropathic pain 1. Diarrhoea predominant irritable bowel syndrome, 2. Diarrhea predominant irritable bowel syndrome 1. Diastolic heart failure, 2. Heart failure 1. Disease Crohns 1. Dry eye 1. Dry eyes, 2. Dry eye syndrome 1. Endometrial carcinoma, 2. Endometrial carcinoma recurrent, 3. Papillary serous endometrial carcinoma 1. Erectile dysfunction, 2. Erectile disturbance, 3. Male erectile disorder, 4. Erectile dysfunction NOS 1. Eye disorders 1. Fibromyalgia 1. Focal epilepsy 1. Frontotemporal dementia, 2. Alzheimer's disease 1. Functional dyspepsia 1. Gastrointestinal stromal tumor 1. Gastrointestinal stromal tumor, 2. Gastrointestinal stromal tumour, 3. Neoplasms benign, malignant and unspecified (incl cysts and polyps) 1. Generalised tonic-clonic seizures 1. Geographic atrophy 1. Germ cell cancer 1. Graft versus host disease in intestine, 2. Graft versus host disease in GI tract 1. Growth hormone deficiency 1. Haemophilia A (Factor VIII) 1. Heart failure 1. Heart failure with reduced ejection fraction 1. Heart failure, 2. Type 2 diabetes mellitus 1. Hemofília A (faktor VIII.), 2. Hemofília B (faktor IX.) 1. Hemorrhage 1. Hepatic impairment 1. Hepatoblastomas, 2. Neuroblastoma, 3. Soft tissue sarcomas, 4. Osteosarcoma, 5. Rhabdomyosarcomas, 6. Ewing's sarcoma 1. Hereditary angioedema 1. Hidradenitis suppurativa 1. Hot flashes 1. House dust mite allergy, 2. Allergic asthma 1. HPV 2. Cervikálna dysplázia vysokého stupňa (HSIL) 1. Human papilloma virus test positive, 2. Cervical high grade squamous intraepithelial lesion 1. Hyperglycemia 1. Hypercholesterolaemia 1. Hypercholesterolemia 1. Hypercholesterolemia, 2. Dyslipidemia 1. Hyperparathyroidism secondary 1. Hyperphosphatemia 1. Choroidal neovascularization 1. Chronic heart failure 1. Chronic inflammatory demyelinating polyradiculoneuropathy 1. Chronic kidney disease 1. Chronic kidney disease stage 3, 2. Chronic kidney disease stage 5, 3. Chronic kidney disease stage 4 1. Chronic kidney disease stage 4, 2. Chronic kidney disease stage 5, 3. Chronic kidney disease stage 3 1. Chronic lymphocytic leukemia refractory 1. Chronic lymphoid leukemia 1. Chronic obstructive pulmonary disease 1. Chronic spontaneous urticaria 1. Chronic venous insufficiency 1. chronické ochorenie obličiek, 2. diabetes II. typu 1. IBD, 2. Ulcerative colitis, 3. Ulcerative colitis, unspecified, 4. Gastrointestinal disorders 1. Ileitis terminal 1. Incomplete bladder emptying, 2. Residual urine, 3. Bladder retention, 4. Detrusor muscle weakness, 5. Weakness detrusor muscle 1. Infected skin ulcer 1. Infection urinary tract 1. Infekčná hnačková choroba zapríčinená Clostridium difficile, 2. Hnačka, Clostridium difficile 1. Influenza viral infections 1. Ischaemic coronary artery disorders 1. Ischemic stroke, 2. Secondary prevention 1. Klasický Hodgkinov lymfóm 2. Hodgkinova choroba 3. Hodgkinova choroba NEC 4. Hodgkinov lymfóm 5. Choroby krvi a lymfatického systému 6. Zhubné a nezhubné nádory, nádory s neurčitým alebo neznámym správaním 1. Knee osteoarthritis, 2. Hips osteoarthritis 1. Leg ulcer 1. Leukemia lymphoblastic acute 1. Lung cancer non-small cell stage III 1. Lung carcinoma cell type unspecified stage IV 1. Lymphoblastic lymphoma 1. Major depression 1. Major depressive disorder, recurrent episode 1. Malignant glioma 1. Malignant melanoma 1. Malignant solid tumor, 2. Neoplasm malignant 1. Malignant solid tumor, 2. Solid tumor, 3. Hematological malignancy, 4. Hepatic impairment 1. Metastatic breast cancer 1. Metastatic colorectal cancer 1. Metastatic gastric cancer 1. Metastatic renal cell carcinoma 1. Metastatic squamous cell carcinoma 1. Migraine 1. Multiple sclerosis relapse 1. Multiple sclerosis, 2. Multiple sclerosis relapse 1. Myelodysplastic syndrome 1. Nealkoholová steatohepatitída, 2. Hepatická fibróza 1. Neoplasm malignant 1. Neoplasms benign, malignant and unspecified (incl cysts and polyps) 1. Neovascular age-related macular degeneration 1. Neovascular age-related macular degeneration, 2. Wet macular degeneration 1. Nervous system disorders, 2. Relapsing-remitting multiple sclerosis 1. Neurodevelopmental disorder, 2. Hypersalivation 1. Neuropathic pain, 2. Lumbar radiculopathy 1. Neutropenia, 2. Febrile neutropenia 1. Nodular (follicular) lymphoma 1. Non-alcoholic steatohepatitis 1. Non-small cell lung cancer 1. Non-small cell lung cancer metastatic 1. Non-small cell lung cancer NOS 1. Non-small cell lung cancer stage IV, 2. Non-small cell lung cancer metastatic, 3. Non-small cell lung cancer recurrent, 4. Non-small cell lung cancer 1. Non-small cell lung cancer stage IV, 2. Non-small cell lung cancer recurrent, 3. Non-small cell lung cancer 1. Non-small cell lung cancer stage IV, 2. Non-small cell lung cancer stage IIIB 1. Nosocomial pneumonia 1. Obesity, 2. Overweight 1. Oesophageal adenocarcinoma, 2. Adenocarcinoma gastric 1. Onychomycosis 1. Ovarian cancer NOS 1. Ovarian epithelial cancer metastatic 1. Overactive bladder 1. Pancreatic carcinoma metastatic 1. Parkinson's disease 1. Parkinson's disease and parkinsonism 1. Paroxysmal atrial fibrillation 1. Partial epilepsy 1. Partial seizures NOS 1. Peripheral revascularization 1. Plaque psoriasis 1. Plasma cell myeloma 1. Polycythemia vera 1. Pompe's disease late onset 1. Post herpetic neuralgia 1. Post polycythemia vera myelofibrosis, 2. Post essential thrombocythemia myelofibrosis, 3. Post polycythaemia vera myelofibrosis, 4. Post essential thrombocythaemia myelofibrosis, 5. Polycythemia vera, 6. Thalassemia, 7. Acute graft versus host disease in intestine, 8. Acute graft versus host disease in skin, 9. Acute graft versus host disease in liver, 10. Acute graft versus host disease, 11. Chronic graft versus host disease, 12. Chronic graft versus host disease in liver, 13. Chronic graft versus host disease in intestine, 14. Chronic graft versus host disease in skin 1. Progression of prostate cancer, 2. Hormone-refractory prostate cancer 1. Progressive relapsing multiple sclerosis 1. Progressive supranuclear palsy 1. Prostate cancer metastatic, 2. Castration-resistant prostate cancer 1. Prostate carcinoma 1. Psoriasis 1. Psoriasis vulgaris 1. Psoriatic arthritis 1. Psoriatic arthritis, 2. Axial spondyloarthritis 1. Psychiatric disorders 1. Pulmonary alveolar proteinosis 1. Pulmonary arterial hypertension 1. Pyelonephritis acute, 2. Urinary tract infections 1. Relapsing-remitting multiple sclerosis 1. Renal tubular acidosis 1. Reproductive system and breast disorders 1. Respiratory syncytial virus infection 1. Respiratory, thoracic and mediastinal disorders 1. Respiratory, thoracic and mediastinal disorders, 2. Idiopathic pulmonary fibrosis 1. Retinal vein occlusion 1. Retinopathy of prematurity 1. Rheumatoid arthritis 1. Rheumatoid arthritis and associated conditions 1. Secondary progressive multiple sclerosis 1. Sensorineural hearing loss 1. Severe pre-eclampsia 1. Schizophrenia 1. Skin bacterial infection 1. Small cell lung cancer 1. Small cell lung cancer extensive stage 1. Solid tumor 1. Spastic hemiparesis 1. Stroke, 2. Myocardial infarction 1. Suicidal ideation, 2. Major depression, 3. Depression suicidal, 4. Suicidal behaviour 1. Testicular germ cell cancer, 2. Seminoma, 3. Non-seminoma testicular cancer 1. Tetanus immunization, 2. Diphtheria immunisation 1. Thermal burns 1. Treatment-resistant schizophrenia 1. Trigeminal neuralgia 1. Triple negative breast cancer 1. Type 1 diabetes mellitus 1. Type 2 diabetes mellitus 1. Type 2 diabetes mellitus, 2. Hyperglycemia 1. Type II diabetes mellitus 1. Type II diabetes mellitus inadequate control 1. Type II diabetes mellitus inadequate control, 2. Type 2 diabetes mellitus, 3. Non-insulin-dependent diabetes mellitus, 4. Type II diabetes mellitus, 5. Diabetes mellitus non-insulin-dependent 1. Type II diabetes mellitus with renal manifestations 1. Ulcerative colitis 1. Ulcerative colitis, 2. Disease Crohns 1. Ulcerózna kolitída, 2. Crohnova choroba 1. Urinary tract infection 1. Urothelial carcinoma 1. Uterine fibroids, 2. Fibroids, 3. Intramural leiomyoma of uterus 1. Vaginitis, 2. Vaginal infection, 3. Non-specific vaginitis, 4. Acute vaginitis, 5. Vaginitis bacterial 1. Venous thromboembolism 1. Venous thromboembolism prophylaxis 1. Vrodené genetické poruchy 2. Niemann-Pickova choroba 1. Vulvovaginitis 1. Wet age-related macular degeneration 1. Wet macular degeneration, 2. Eye disorders, 3. Neovascular age-related macular degeneration Acute heart failure Acute Myeloid Leukemia Akromegália akútna myeloidná leukémia Akútne zlyhanie pečene v teréne chronického poškodenia akútny infarkt myokardu Akútny koronárny syndróm Alergia na roztoče z domáceho prachu Alergická rinitída/rinokonjunktivitída vyvolaná roztočmi domáceho prachu s astmou alebo bez astmy Alzheimer’s disease Anémia Ankylozujúca spondylitída Antikoncepcia Arteriosklerotické kardiovaskulárne ochorenie Asthma Astma Atopická dermatitída Axiálna spondyloartritída, Nerádiografická axiálna spondyloartritída, Ankylozujúca spondylitída bez indikácie Bioekvivalenčná štúdia
dvoch perorálnych liekových foriem – Metoprolol Saneca 100 mg tablety (Saneca, Slovakia) a Seloken 100 mg tablety (AstraZeneca S.p.A., Italy) – po jednorazovej dávke zdravým účastníkom nalačno. Bioekvivalenčná štúdia
dvoch perorálnych liekových foriem – Zolpidem Saneca 10 mg, filmom obalené tablety (Saneca, Slovakia) a Stilnox 10 mg, filmom obalené tablety (Sanofi-Aventis Slovakia s.r.o., Slovakia) – po jednorazovej dávke zdravým účastníkom nalačno. Bipolárna porucha 1. typu Bolesti v dôsledku kostných metastáz COVID-19 Crohnova choroba Cystická fibróza Demencia Alzheimerovho typu Depresívna porucha Diabetes mellitus 2. typu Diabetes mellitus 2. typu, Chronické ochorenie obličiek Diabetes mellitus II typu Diabetic Nephropathy:
Adults (age 18 - 90 years inclusive) with type 2 diabetes, an eGFR of 25-59 mL/min/1.73 m2, and with macroalbuminuria (>300 mg/g) will be randomized. diabetická nefropatia Diabetická retinopatia Diabetický makulárny edém Diverzifikovaný liposarkóm, Leiomyosarkóm dyslipidémia English Asthma Epilepsia Gastroezofageálny reflux Generalizované tonicko-klonické záchvaty Glaukóm a očná hypertenzia healthy volunteers (intended for symptomatic treatment of Lambert-Eaton myasthenic syndrome)
mild, moderate and severe renal impairment (intended for symptomatic treatment of Lambert-Eaton myasthenic syndrome) Heart Failure hepatic impaired patients hepatic impaired patients and healthy volunteers Hereditárna hemochromatóza Hidradenitis suppurativa Hypercholesterolémia, Dislipidémia Chronic Heart Failure (HF) with Reduced Ejection Fraction chronic obstructive pulmonary disease (COPD) Chronická fáza chronickej myeloidnej leukémie Chronická choroba obličiek Chronická lymfocytová leukémia (CLL) Chronická obštrukčná choroba Chronická obštrukčná choroba pľúc Chronická spontánna urtikária Chronická tromboembolická pľúcna hypertenzia Chronické srdcové zlyhanie Chronický kašeľ refraktérny Idiopatická pľúcna fibróza Infarkt myokardu s eleváciou ST segmentu Infekcia chrípky typu A Infekcie močových ciest infekcie vyvolané gramnegatívnymi patogénmi Ischemická cievna mozgová príhoda Ischemická cievna mozgová príhoda spojená s fibriláciou predsiení Karcinóm hlavy a krku Karcinóm prostaty Karcinóm prsníka Kardiovaskulárne komplikácie u diabetických pacientov Kardiovaskulárne ochorenie Krátkozrakosť Ložisková psoriáza Lupusová nefritída Lymfóm z plášťových buniek, Lymfóm z marginálnej zóny, Waldenströmová makroglobulinémia Malobunkový karcinóm pľúc Melanóm Metastatický hormonálne senzitívny karcinóm prostaty Metastatický karcinóm prostaty Metastatický karcinóm prsníka metastatický kastračne rezistentný karcinóm prostaty (mCRPC). Migréna Mild and Moderate Hepatic Impaired Patients and Healthy Volunteers (Intended for Treatment Of Moderate to Severe Acute Pain) Mild and moderate hepatic impairment, healthy volunteers
(intend for treatment of Nonalcoholic Steatohepatitis (NASH) with Liver Fibrosis) MILD AND MODERATE HEPATIC IMPAIRMENT, HEALTHY VOLUNTEERS (INTENDED FOR TREATMENT OF EPILEPSY) MILD, MODERATE AND SEVERE RENAL IMPAIRMENT, HEALTHY VOLUNTEERS (INTENDED FOR TREATMENT OF ANXIETY, EPILEPSY) Mild, moderate, severe hepatic impaired subjects and healthy
volunteers Mild, moderate, severe renal impaired subjects and healthy volunteers. (IMP is intended for treatment of cardiovascular diseases - Pulmonary arterial hypertension) Mnohopočetný myelóm Nádorové ochorenia Nedostatok rastového hormónu Nefropatia Nemalobunkový karcinóm pľúc Nemalobunkový karcinóm pľúc v štádiu III Neovaskulárna vekom podmienená degenerácia makuly Neskvamocelulárny nemalobunkový karcinóm pľúc Neskvamózna nemalobunková rakovina pľúc (NSCLC) Neuropatická bolesť spôsobená lumbosakrálnou radikulopatiou non - Hodgkinov lymfóm Non-Hodgkinov lymfóm Non-Small Cell Lung Cancer Nozokomiálna pneumónia Odmietnutie transplantovanej obličky Oklúzia vetvy sietnicovej žily Operácia katarakty Osteoarthritis of the hip or knee osteoartritická bolesť kolenného kĺbu Parkinsonova choroba paroxyzmálna supraventrikulárna tachykardia Patients with an advanced solid tumor combined with moderate hepatic impairment and patients with an advanced solid tumor with normal hepatic function will be enrolled. Pneumokoková imunizácia Pokročilý alebo metastatický uroteliálny alebo non-uroteliálny karcinóm močových ciest Porucha autistického spektra Primárna biliárna cholangitída Primárne imunodeficiencie Primárny glaukóm s otvoreným uhlom, Očná hypertenzia Primary immunodeficiency Psoriatická artritída Rakovina prostaty rakovina vaječníkov Recidivujúci non- Hodgkinov lymfóm Refractory histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma germ cell tumours Relabujúca roztrúsená skleróza Relapsujúca - remitujúca skleróza multiplex Relapsujúca roztrúsená skleróza Relapsujúca skleróza multiplex renal impaired patients and healthy subjects Renal impairment Retinal Vein Occlusion Retinopatia nedonosených detí Reumatoidná artritída Seasonal allergic rhinoconjunctivitis and asthma Skleróza multiplex skvamózny nemalobunkový karcinóm pľúc srdcové zlyhanie, kardiovaskulárne ochorenia Srdcové zlyhávanie Srdcové zlyhávanie so zachovanou ejekčnou frakciou Syndróm primárnej imunodeficiencie Štúdia bioekvivalencie dvoch perorálnych liekových foriem - Duloxgamma 60 mg tvrdé gastrorezistentné kapsuly (Wörwag, Germany) a Cymbalta® 60 mg tvrdé gastrorezistentné kapsuly (Eli Lilly) – po jednorazovej dávke zdravým účastníkom nalačno. Štúdia bioekvivalencie dvoch perorálnych liekových foriem - Duloxgamma 60 mg tvrdé gastrorezistentné kapsuly (Wörwag, Germany) a Cymbalta® 60 mg tvrdé gastrorezistentné kapsuly (Eli Lilly) – po jednorazovej dávke zdravým účastníkom po jedle. Tardivné dyskinézie Testing for adrenal cortical adenomas in male and female patients
Testing for uterine endometrial stromal sarcromas in all female patients Triple-negatívny karcinóm prsníka Ulcerative Colitis Ulceratívna kolitída Ulceratívna proktitída Ulcerózna kolitída ulcerózna kolitída Uroteliálny karcinóm Vekom podmienená degenerácia makuly Veľká depresívna porucha Venózna trombóza Vertigo Vulvovaginálna candidóza vyšetrenie CNS pomocou MRI Zápcha vyvolaná opioidmi Zdravý dobrovolníci.
Prvé podanie určené k zhodnoteniu znášanlivosti a základných farmakokinetických parametrov.
