TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01756105
Drug: Rapid acting analog insulin Intermediate acting NPH Insulin
Normalized name: Insulins and analogs for injection, intermediate-acting combinations
Approvals — FDA: no, EMA: no, PMDA: no
Description: Insulin therapy:If post meal (2 hours after meal) glycaemia is \> to 120 mg/dl introduce Insulin rapid acting analog (Humalog\*, Novorapid\*) before the meal concerned and according to the weight. If weight is \< 80 kg: breakfast 5U, lunch time 3U, and dinner 4U. If weight is \> 80 kg :breakast 6U, lunch time 4U, dinner 5U.If post meal glycaemia stay over 120 mg/dl but lower than130 mg/dl: do 1 U more.If post meal glycaemia stay over 140 mg/dl : do 2 UI moreIf fasting glycaemia is over 95 mg/dl : introduce NPH Insulin (Umuline NPH\*, insulatard\*) before sleeping : 5U if weight is \< 80 kg - 6U if weight is \> 80 kgIf fasting glycaemia stay over 95 mg/dl increase NPH Insulin for 1 U and for 2 U if fasting glycaemia is over 110 mg/dl.
Study: NCT03017326
Drug: 5Fluorouracil
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Arm C used alone
Study: NCT03603951
Drug: SHR2554
Approvals — FDA: no, EMA: no, PMDA: no
Description: SHR2554 is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2.
Study: NCT03051698
Drug: Antibiotics
Normalized name: Antibiotics
Approvals — FDA: no, EMA: no, PMDA: no
Description: vancomycin, ciprofloxacin, metronidazole
Study: NCT01196689
Drug: AZD1981 100 mg twice daily for 61/2 days
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100 mg tablets
Study: NCT01801358
Drug: AEB071
Approvals — FDA: no, EMA: no, PMDA: no
Description: Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles)
Study: NCT01801358
Drug: MEK162
Approvals — FDA: no, EMA: no, PMDA: no
Description: Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)
Study: NCT01918033
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo to desloratadine 5 mg tablets
Study: NCT03265132
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: sub cutaneous injection
Study: NCT01407874
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral dose administered daily for 84 days.
Study: NCT00088166
Drug: placebo hCRF
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo hCRF 2mg/day and open-label dexamethasone that they are taking
Study: NCT02137785
Drug: Aminolevulinic Acid (ALA)
DrugBank: Aminolevulinic acid (DB00855)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Study: NCT01844206
Drug: Epidural Saline
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Study: NCT03114215
Drug: MD1003
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsules 100mg 3 times per day
Study: NCT00691899
Drug: placebo (unspecified)
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo; oral, once daily for Approximately 36 months
Study: NCT03114215
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: capsules 100mg lactose 3 times per day
Study: NCT01735214
Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Study: NCT03912818
Drug: Doxorubicin
Normalized name: Doxorubicin
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV
Study: NCT03912818
Drug: Methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00431665
Drug: heparin
Normalized name: Heparin
DrugBank: Heparin (DB01109)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT02400567
Drug: Fluorouracile
Normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02400567
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01397539
Drug: BIIB037
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg.
Study: NCT05706090
Drug: fentanyl will be added
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: If adequate anagesia is not provided with the block, 1 microgram/kg of fentanyl will be added
Study: NCT02968433
Drug: Infusions of young plasma
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)
Study: NCT03287414
Drug: VAY736
Approvals — FDA: no, EMA: no, PMDA: no
Description: 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks
Study: NCT03287414
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo administered subcutaneously every 4 weeks for 48 weeks
Study: NCT03287414
Drug: Standard of Care (SoC)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy
Study: NCT00546676
Drug: Telithromycin
Normalized name: Telithromycin
DrugBank: Telithromycin (DB00976)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT03817411
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).
Study: NCT00836602
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral Solution, Oral, 0 mg, Once daily, 7 days
Study: NCT00161070
Drug: anticoagulation
Normalized name: monitoring agent for oral anticoagulation
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01865916
Drug: Polyethylene Glycol (PEG) + ascorbic acid
Normalized name: Polyethylene Glycol
DrugBank: Polyethylene glycol (DB09287)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be asked to take split dose of 2L PEG and vitamin C
Study: NCT01960530
Drug: Hydrocortisone granules
Normalized name: hydrocortisone Granule Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: Multi-particulate granules
Study: NCT01960530
Drug: Hydrocortisone Tablet
Normalized name: Hydrocortisone Tablets
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Standard hydrocortisone tablets
Study: NCT01960530
Drug: i.v. Hydrocortisone Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: Standard hydrocortisone solution for intravenous injection
Study: NCT01301274
Drug: hypotonic
Normalized name: Hypotonic Tears
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.45% NaCl/5% dextrose IV maintenance fluids
Study: NCT01301274
Drug: isotonic
Normalized name: Isotonic solutions
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.9% NaCl/5% dextrose IV maintenance fluids
Study: NCT04211415
Drug: DS-2741a
Normalized name: Uretron DS
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks
Study: NCT04211415
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single, subcutaneous injection administered weekly for 4 weeks
Study: NCT03817411
Drug: Placebos
Approvals — FDA: no, EMA: no, PMDA: no
Description: 300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
Study: NCT00570622
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients receive placebo once a day orally for 9 days
Study: NCT00886834
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pills which are identical to the study drug in appearance, taste, and smell.
Study: NCT01430780
Drug: control group
Normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT02750475
Drug: Sunscreen Sport Lotion (BAY987516)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50 μl/cm\*2 or 0.05 gm/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm\*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)
Study: NCT03122860
Drug: SM04690
Approvals — FDA: no, EMA: no, PMDA: no
Description: Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
Study: NCT01600274
Drug: Dienogest-Ethinyl Estradiol (test product)
Normalized name: dienogest / ethinyl estradiol
Approvals — FDA: no, EMA: no, PMDA: no
Description: One tablet of Test
Study: NCT01600274
Drug: Dienogest-Ethinyl Estradiol (reference product)
Normalized name: dienogest / ethinyl estradiol
Approvals — FDA: no, EMA: no, PMDA: no
Description: One tablet of Reference
Study: NCT00626366
Drug: Omnipaque 240 Contrast Solution
Normalized name: Contrased
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
Study: NCT00626366
Drug: Omnipaque 240 mg I/mL
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
Study: NCT01253174
Drug: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)
Approvals — FDA: no, EMA: no, PMDA: no
Description: single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
Study: NCT01253174
Drug: EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)
Approvals — FDA: no, EMA: no, PMDA: no
Description: single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin
Study: NCT01253174
Drug: L-5-MTHF Ca 0.451 mg (Metafolin)
Approvals — FDA: no, EMA: no, PMDA: no
Description: single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin
Study: NCT02055079
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fixed oral dose of 3 mg placebo (blinded) once weekly for 24 months.
Study: NCT00001255
Drug: ADA PBSC
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT06153784
Drug: Hydroxyurea and Thalidomide
Normalized name: Thalidomide
DrugBank: Thalidomide (DB01041)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Evaluation of hydroxyurea and thalidomide combination use in beta-thalassemia patients
Study: NCT04655040
Drug: Caffeine
Normalized name: Caffeine
DrugBank: Caffeine (DB00201)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 100milligram (mg) tablet taken orally in period 1 and period 2
Study: NCT00375050
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo
Study: NCT02244346
Drug: Secotex®
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02395263
Drug: Yuxintine
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01071239
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Chemotherapy administered as a part of the HSCT conditioning regimen.
Study: NCT01000649
Drug: FE 202158 1.25
Approvals — FDA: no, EMA: no, PMDA: no
Description: FE 202158 at dose 1.25 ng/kg/min infused.
Study: NCT01000649
Drug: FE 202158 3.75
Approvals — FDA: no, EMA: no, PMDA: no
Description: FE 202158 at dose 3.75 ng/kg/min infused.
Study: NCT03076944
Drug: UltraEZ
Approvals — FDA: no, EMA: no, PMDA: no
Description: Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.
Study: NCT03076944
Drug: Enamelast
Normalized name: Enamelast
Approvals — FDA: no, EMA: no, PMDA: no
Description: Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.
Study: NCT01807650
Drug: Oleogel-S10, non-adhesive wound dressing
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28
Study: NCT02761317
Drug: standard preparation (2L PEG-ELS)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects who are randomized into group A will receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.
Study: NCT00600990
Drug: GW597599
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00838799
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: TID, capsules, 14 weeks.
Study: NCT03116191
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 4 weeks of repeated administration of Placebo to the patients of nocturia
Study: NCT01537497
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
Study: NCT02732132
Drug: Propofol and Fentanyl
Normalized name: Propofol
DrugBank: Propofol (DB00818)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: This group was injected intravenous fentanyl 1 mcg/kg, and two minutes later, propofol 1 mg/kg was given intravenously before the start of endoscopy.
Study: NCT00904202
Drug: Placebo Capsules + Placebo Patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
Study: NCT00904202
Drug: Placebo capsules + Lidoderm®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).
Study: NCT04199767
Drug: 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
Study: NCT04199767
Drug: 40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
Study: NCT02073097
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV (750mg/m\^2)
Study: NCT02073097
Drug: Doxorubicin hydrochloride
Normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given IV (50mg/m\^2)
Study: NCT04495816
Drug: Omega-3 Fatty Acid Supplement
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants randomized to this arm will be instructed to take two of the softgels they received per day for 6 weeks. They will receive softgels containing 1,000 mg of omega-3 fatty acid. 1000 mg of omega-3 fatty acid blend including 683 mg Eicosapentaenoic Acid and 252 mg Docosahexaenoic Acid
Study: NCT04495816
Drug: Placebo/Control
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients randomized to this arm will also be instructed to take two of the softgels they received per day for 6 weeks. They will receive placebo softgels that are indistinguishable from those containing fish oil.
Study: NCT00001579
Drug: Ethynyluracil
Normalized name: 5-Ethynyluracil
DrugBank: Eniluracil (DB03516)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00001579
Drug: Leucovorin
Normalized name: Leucovorin
DrugBank: Leucovorin (DB00650)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT02363049
Drug: Chemotherapy
Normalized name: Chemotherapy Glove SML
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00004784
Drug: methotrexate
Normalized name: Methotrexate
DrugBank: Methotrexate (DB00563)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT01168310
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inhalation Solution
Study: NCT01885559
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Study: NCT01881997
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Fentanyl Intramuscular (IM), 1ugm/kg, x1
Study: NCT01881997
Drug: Normal Saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: IM normal saline
Study: NCT02318810
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients receive saline
Study: NCT01342497
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: tablets, dosing 3 times daily, 12 weeks
Study: NCT01787097
Drug: Symbicort® total dose 400ug/12ug
Approvals — FDA: no, EMA: no, PMDA: no
Description: Symbicort® is combination of formoterol 400ug and budesonide 12ug. Single dose
Study: NCT01787097
Drug: Symbicort® total dose 800ug/24ug
Approvals — FDA: no, EMA: no, PMDA: no
Description: Symbicort® is combination of formoterol 800ug and budesonide 24ug. Single dose
Study: NCT00949884
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo oral tablets once daily for two weeks
Study: NCT01217736
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: single dose, tablet
Study: NCT01527487
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.
Study: NCT00242281
Drug: APC-111 MP Tablet, 775 mg
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00125021
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
Study: NCT03070301
Drug: LEE011
Approvals — FDA: no, EMA: no, PMDA: no
Description: LEE011 200 mg daily
Study: NCT04692766
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Normal Saline (0.9% Sodium Chloride solution for Injection), 5 mL in a polypropylene ampoule, 10 ampoules per labeled package
Study: NCT01210495
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID
Study: NCT00648934
Drug: Topamax® Sprinkle Capsules 25 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: 25mg, single dose fed
Study: NCT00751257
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Identically appearing placebo capsules, packaged in an N-acetylcysteine slurry so that placebo has similar odor as active NAC capsules
Study: NCT02193139
Drug: WL8713, 6 mg
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02193139
Drug: WL8713, 12 mg
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02193139
Drug: WL8713, 18 mg
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02193139
Drug: WL8713, 24 mg
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02193139
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01471717
Drug: INX-08189 50 mg QD X 5 days
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cohort 1: Subjects will begin administration of INX-08189 50 mg QD on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose.
Study: NCT01471717
Drug: INX-08189 / Victrelis 800 mg TID X three days
Approvals — FDA: no, EMA: no, PMDA: no
Description: Cohort 1: INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days (Study Days 5 through 7)
Study: NCT01471717
Drug: Victrelis 800 mg TID x 3 days
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Cohort 2, subjects will begin administration of Victrelis 800 mg TID on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days (Study Days 0 through 2).
Study: NCT01471717
Drug: Victrelis 800 mg TID with INX-08189 50 mg QD
Normalized name: thiamine
DrugBank: Thiamine (DB00152)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days (Study Days 3 through 7).
Study: NCT01471717
Drug: Placebo with Victrelis 800 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
Study: NCT01471717
Drug: Cohort 2: Victrelis 800 mg with Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
Study: NCT03610685
Drug: Prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Given daily for 2 weeks
Study: NCT03610685
Drug: Placebo oral capsule
Normalized name: Placebo Oral Capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given daily for 2 weeks
Study: NCT01139190
Drug: PL3100
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration
Study: NCT01139190
Drug: Naproxen
Normalized name: Naproxen
DrugBank: Naproxen (DB00788)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Oral administration
Study: NCT02293395
Drug: Acetylsalicylic acid
Normalized name: ACETYLSALICYLIC ACID
DrugBank: Acetylsalicylic acid (DB00945)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: ASA 100 mg enteric-coated tablet once daily orally.