TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04044547
Drug: Placebo, extended-release microspheres
Approvals — FDA: no, EMA: no, PMDA: no
Description: Four stable dose levels of placebo at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:~* Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.~* Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.~* Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.~* Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks.
Study: NCT01190657
Drug: Selbex
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50mg/day, 3 times/day, for 14 days
Study: NCT01190657
Drug: Selbex
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50mg/day, 3 times/day, for 56 days
Study: NCT02985216
Drug: YHD1119
Approvals — FDA: no, EMA: no, PMDA: no
Description: YHD1119 150mg, PO YHD1119 300mg, PO~YHD1119 600mg, PO
Study: NCT02029157
Drug: ARQ197
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02029157
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00398528
Drug: IFN-β-1a, (Avonex®)
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01123304
Drug: MORAb028
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.
Study: NCT03170336
Drug: Amiloride
Normalized name: Amiloride
DrugBank: Amiloride (DB00594)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Amiloride first for 8 weeks, then for a washout for 4 weeks, and cross over to receive hydrochlorothiazide for another 8 weeks.
Study: NCT01943630
Drug: 15% AS101 gel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of Topical 15% AS101 once a day (overnight)
Study: NCT01943630
Drug: Vehicle
Normalized name: Drug vehicle
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of Vehicle once a day (overnight)
Study: NCT03591705
Drug: TACE-HAIC
Approvals — FDA: no, EMA: no, PMDA: no
Description: transcatheter arterial chemo-lipiodolization with EADM 30mg/m2, followed by hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
Study: NCT03591705
Drug: HAIC
Normalized name: Hepatic Arterial Infusion Chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
Study: NCT02940886
Drug: Iron isomaltoside/ferric derisomaltose
Approvals — FDA: no, EMA: no, PMDA: no
Description: Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes.
Study: NCT01025713
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Inhaled Placebo
Study: NCT03073603
Drug: Standard of Care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants who remain on their current Disease Modifying Therapies (DMTs) without any changes. DMTs include \~14 formulations/doses of drugs approved in the US by the FDA that alter the natural history of the disease.
Study: NCT01181934
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo - three times daily during each treatment period
Study: NCT01205243
Drug: ZIAGEN®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Basically there is no treatment allocation. Subjects who would be administrated ZIAGEN® at their physician's discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
Study: NCT02473952
Drug: IGIV-C
Approvals — FDA: no, EMA: no, PMDA: no
Description: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
Study: NCT02473952
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02312739
Drug: Standard Oral pain medications
Approvals — FDA: no, EMA: no, PMDA: no
Description: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Study: NCT02312739
Drug: Intramuscular Ketorolac
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Study: NCT02312739
Drug: Placebo pills
Normalized name: placebo Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Study: NCT04711265
Drug: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intramuscular injection with 3 doses of QHPV
Study: NCT00861939
Drug: WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04434404
Drug: L-Carnitine 500Mg Oral Tablet
Normalized name: L-Carnitine 500mg Oral tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: eighty-three eligible patients were recruited 33, 25, and 25 patients in the control group, L-carnitine group, and, Silymarin group respectively, completed the study~without cardioprotective agents in a dose of 50 mg/m2. L-carnitine group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine 3 gm L-carnitine® capsules obtained from (MEPACO) was taken PO one day before chemotherapeutic cycle and 1gm /day during the following 21 days. Silymarin group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin as cardioprotective agent.140 mg (Legalon ® 140 mg capsule obtained from (MEDA). Silymarin was taken PO once daily after meals during the chemotherapeutic cycle. The treatment period was 6 months.
Study: NCT03903029
Drug: Low-dose (10mg) rosuvastatin
Normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline
Study: NCT03701555
Drug: PvP001 100 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: PvP001 100 mg
Study: NCT03701555
Drug: PvP001 300 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: PvP001 300 mg
Study: NCT03701555
Drug: PvP001 900 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: PvP001 900 mg
Study: NCT03701555
Drug: PvP001 600 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: PvP001 600 mg
Study: NCT03701555
Drug: PvP003 placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo tablet orally.
Study: NCT03701555
Drug: PvP003
Approvals — FDA: no, EMA: no, PMDA: no
Description: PvP003 tablet orally.
Study: NCT03701555
Drug: PvP003 150 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: PvP003 150 mg
Study: NCT02185352
Drug: BEEP regimen
Normalized name: Anacin Aspirin Regimen Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bevacizumab 15mg/kg IVF on D1, Etoposide 70 mg/m2 IVF QD, D2-4, Cisplatin 70 mg/m2 IVF on D2, repeat every 3 weeks, for 3 cycles
Study: NCT00646802
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
Study: NCT03051932
Drug: Ofiramev® (IV Acetaminophen)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Post -op pain medication
Study: NCT03051932
Drug: Placebo IV administration
Approvals — FDA: no, EMA: no, PMDA: no
Description: Post -op pain
Study: NCT03351998
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo pill.
Study: NCT03544632
Drug: Acellular Adipose Tissue (AAT)
Normalized name: acellular tissue engineered vessel
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants (n=15) will be administered between 5cc and 20cc of AAT, depending on their assigned treatment group, via sterile subcutaneous injection into the target defect. The injection is intended to be permanent. After the 3-month study follow-up visit, participants will have the option to undergo additional AAT injection (up to 20cc per treatment) in order to fully correct the defect. Total injected AAT volume per patient will not exceed 40cc. Additional injection is dependent upon study- and patient-specific adverse / unanticipated events to date.~Each vial contains a 2 milliliter (mL) dose of the injectable AAT. This volume is similar to other commonly used injectable filler materials intended for soft tissue correction.
Study: NCT06445465
Drug: [18F]MNI-1216
Approvals — FDA: no, EMA: no, PMDA: no
Description: \[18F\]MNI-1216 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of α-synuclein deposits.
Study: NCT01652092
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: cyclophosphamide 50 mg/kg IV on days -9 through -6
Study: NCT01296568
Drug: LY2603618
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered intravenously
Study: NCT00642278
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
Study: NCT00569920
Drug: natriumchloride 0,9%
Approvals — FDA: no, EMA: no, PMDA: no
Description: iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.
Study: NCT01858662
Drug: 5-Fluorouracile
Approvals — FDA: no, EMA: no, PMDA: no
Description: 5-FU bolus 400 mg/m2, IV bolus every 2 weeks 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion every 2 weeks
Study: NCT01858662
Drug: leucovorin L
Approvals — FDA: no, EMA: no, PMDA: no
Description: Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion
Study: NCT03679481
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
Study: NCT03531229
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo to Lu AF76432 oral solution
Study: NCT04018170
Drug: Study drug
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg
Study: NCT04018170
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets
Study: NCT00634543
Drug: Tramadol hydrochloride/ Acetaminophen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive 1 tablet containing tramadol HCl 37.5 milligram (mg) and acetaminophen 325 mg once daily, at bed time on Days 1 to 3,. 1 tablet twice daily on Days 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there is no pain relief, the dosage can be increased up to 8 tablets per day for Days 15 to 28. The increased dose will be maintained for Days 29 to 42.
Study: NCT00685178
Drug: placebo + NonCR
Approvals — FDA: no, EMA: no, PMDA: no
Description: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
Study: NCT00916604
Drug: AZD1656
Approvals — FDA: no, EMA: no, PMDA: no
Description: Three increasing dose-steps with oral suspension, 8 days treatment
Study: NCT00916604
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo oral suspension, 8 days treatment
Study: NCT04524975
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo capsules
Study: NCT00538603
Drug: pegylated liposomal Doxorubicin (CAELYX) & Carboplatin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Chemotherapy
Study: NCT02760602
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered IV
Study: NCT01202773
Drug: LY2127399
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered Subcutaneously (SC)
Study: NCT01202773
Drug: Placebo Q4W
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered SC
Study: NCT01202773
Drug: Placebo Q2W
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered SC
Study: NCT03795298
Drug: Market-approved OAC
Normalized name: acetaminophen
DrugBank: Acetaminophen (DB00316)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
Study: NCT03159754
Drug: Antibiotics
Normalized name: Antibiotics
Approvals — FDA: no, EMA: no, PMDA: no
Description: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Study: NCT00230581
Drug: DDP225
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00950352
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
Study: NCT00978575
Drug: ferricarboxymaltose
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single dose of maximum 1000 mg ferricarboxymaltose intravenous
Study: NCT00978575
Drug: Ferrosulfate
Normalized name: isostearyl ethylimidazolinium ethosulfate
Approvals — FDA: no, EMA: no, PMDA: no
Description: 200mg daily for 12 weeks
Study: NCT00978575
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100 mg isotonic sodium and 2 placebo tablets daily
Study: NCT01454089
Drug: OGX-427 600 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (600 mg IV) on Days 1, 8 and 15 of each 21-day cycle.
Study: NCT01454089
Drug: OGX-427 1000 mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (1000 mg IV) on Days 1, 8 and 15 of each 21-day cycle.
Study: NCT01454089
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive three loading doses of placebo within a 9-day period. Following the loading dose period, patients will receive weekly placebo infusions (IV) on Days 1, 8 and 15 of each 21-day cycle.
Study: NCT02979223
Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid
Approvals — FDA: no, EMA: no, PMDA: no
Description: sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.~There is a difference in the order of intake between two group
Study: NCT00707954
Drug: Placebo of TA-7284
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)
Study: NCT03264638
Drug: Dingkundan & Diane-35
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
Study: NCT04356105
Drug: Microflare protocol
Normalized name: Olay Professional Acne Protocol
Approvals — FDA: no, EMA: no, PMDA: no
Description: OCP, GnRH agonist, Recombinant FSH
Study: NCT00893594
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.
Study: NCT00719173
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Given IV
Study: NCT00117338
Drug: Comparator: placebo (unspecified)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pbo for a study approximately 120 minutes in duration
Study: NCT00680407
Drug: Silymarin 700 mg
Normalized name: silymarin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period
Study: NCT00680407
Drug: Silymarin 420 mg
Normalized name: silymarin
Approvals — FDA: no, EMA: no, PMDA: no
Description: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period
Study: NCT02084953
Drug: Placebo matching BMS-791325
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT02266537
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT00003530
Drug: Antineoplaston therapy (Atengenal + Astugenal)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients with Primary Liver Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Study: NCT04592835
Drug: DWRX2003
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intramuscularly injection at predefined injection sites~Drug: Placebo Intramuscularly injection at predefined injection sites
Study: NCT00647842
Drug: Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay
Approvals — FDA: no, EMA: no, PMDA: no
Description: single application
Study: NCT02467595
Drug: Fentanyl
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Study: NCT02576912
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A placebo dose given sublingually.
Study: NCT02576912
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo dose given intravenously.
Study: NCT00193674
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT00790296
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Saline
Study: NCT00349791
Drug: Testosterone Transdermal System
Normalized name: testosterone Transdermal System
Approvals — FDA: no, EMA: no, PMDA: no
Description: testosterone (300 mcg/day) patch replaced twice a week for two years
Study: NCT00349791
Drug: Placebo patch
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo patch replaced twice a week for two years
Study: NCT00379730
Drug: Prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT04263922
Drug: Huaiqihuang granules
Approvals — FDA: no, EMA: no, PMDA: no
Description: Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
Study: NCT02881619
Drug: Etodolac
Normalized name: Etodolac
DrugBank: Etodolac (DB00749)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The patient will receive a single-dose of Etodolac (400 mg) one hour before the bleaching procedure.
Study: NCT02881619
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The patient will receive a single-dose of placebo one hour before the bleaching procedure.
Study: NCT03704818
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo treatment taken daily for 4-weeks.
Study: NCT00353275
Drug: Strict Glycemic control
Normalized name: Euphrasia stricta extract
Approvals — FDA: no, EMA: no, PMDA: no
Description: Blood glucose target range is 80-110 mg/dL.
Study: NCT04135261
Drug: HBM4003
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous (IV) administration
Study: NCT01299597
Drug: Simvastatin
Normalized name: Simvastatin
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period.
Study: NCT03241173
Drug: INCAGN01949
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1.
Study: NCT02963077
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT03926182
Drug: AST2818 Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1.
Study: NCT03926182
Drug: AST2818 Tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: AST2818 Tablets: Period 1 allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. Period 2 fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once)and 4 hours after dosing on day 1.
Study: NCT04018027
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral Placebo administered twice daily
Study: NCT01245894
Drug: Low-dose Rosuvastatin
Normalized name: ethinyl estradiol
DrugBank: Ethinylestradiol (DB00977)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Rosuvastatin 5mg/day for one year
Study: NCT01245894
Drug: High-dose Rosuvastatin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Rosuvastatin 40mg/day for one year
Study: NCT00894530
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: One drop in each eye twice a day for the first two days; then one drop in each eye once a day for 26 days
Study: NCT03633643
Drug: oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)
Approvals — FDA: no, EMA: no, PMDA: no
Description: five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day~1 and 2 after surgery while the patient is in hospital.
Study: NCT03633643
Drug: oral applications of Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: five oral applications of Placebo at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.
Study: NCT00198237
Drug: docetaxel & capecitabine
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT01177150
Drug: JNJ-28431754/ Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Part 1: One oral dose of JNJ 28431754 (10 mg to 600 mg) or matching placebo will be administered after an overnight fast of at least 10 hours .For patients who receive a previously tested dose as 2 equally divided doses, the evening dose will be administered at 10 hours after the morning dose.