AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Trial: NCT03080493
Drug: acetaminophen/codeine and ibuprofen
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Over the counter analgesic medications
Trial: NCT02590068
Drug: Zoster vaccine live
RxNorm normalized name: zoster vaccine live
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
Trial: NCT00005871
Drug: fluorouracil
RxNorm normalized name: Fluorouracil
DrugBank: Fluorouracil (DB00544)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT03450499
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: the analgesic requirement will be calculated in placebo group.
Trial: NCT00940745
Drug: conservative treatment
RxNorm normalized name: Hongo Killer Treatment
FDA approved: no
EMA approved: no
PMDA approved: no
Description: dehydrating agent, haemostatic In the treatment, under the convention we use the dehydrator for patients, the ultra early patient may use anti-filament medicinal preparation 6- amino-caproic acid 6-12g/d, intravenous drip, the period of revolution does not surpass for 24 hours, then just right for the illness treatment.
Trial: NCT01712061
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Trial: NCT02844777
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200 mg applied once-daily for 28 days
Trial: NCT02844777
Drug: 5% VDA-1102
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200 mg applied once-daily for 28 days
Trial: NCT02844777
Drug: 10% VDA-1102
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 200 mg applied once-daily for 28 days
Trial: NCT00762476
Drug: 3804-250A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * topical product~* apply 2 pumps~* apply at least every 4 hours or after hand washing
Trial: NCT00762476
Drug: 3804-291
RxNorm normalized name: POUCH,OSTOMY H#3804
FDA approved: no
EMA approved: no
PMDA approved: no
Description: * topical~* apply 2 pumps~* apply at least every 4 hours or after hand washing
Trial: NCT01551368
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Identical inactive tablets.
Trial: NCT01882764
Drug: HMPL-004
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given HMPL-004 orally three times per day with total daily dose of 1800 mg for 52 weeks.
Trial: NCT01882764
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given Placebo orally three times per day with total daily dose of 1800 mg for 52 weeks.
Trial: NCT00303238
Drug: Rose hips extract + resveravine + Aframomum melegueta extract
RxNorm normalized name: Aframomum angustifolium seed extract
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02969980
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Cyclophosphamide 50 mg/kg/day i.v. daily on days 3 and 4 of hematopoietic cell transplantation
Trial: NCT01182727
Drug: salsalate
RxNorm normalized name: Salsalate
DrugBank: Salsalate (DB01399)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: Salsalate will be administered in 500 mg tablets. Salsalate will be administered in two divided doses of 2 grams in the morning and 2 grams in the evening. Salsalate will be administered for a total of 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until tolerated or a minimum dose of 2 grams per day is achieved.
Trial: NCT01055704
Drug: Codeine only
RxNorm normalized name: Codeine only product
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 30 mg taken orally four times daily for 5 days
Trial: NCT01055704
Drug: Methylnaltrexone + codeine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days
Trial: NCT01055704
Drug: Placebo + placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Placebo subcutaneous injection once daily and placebo taken orally four times daily for 5 days
Trial: NCT02223247
Drug: TVB-2640
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02351882
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Participants randomized to placebo arm, will undergo a one-week placebo washout, followed by 6 weeks of drug matched placebo (weeks 1-6). Participants will then receive a one-week placebo washout (week 7), before receiving 6 weeks of nabilone treatment (weeks 8-14).
Trial: NCT03657264
Drug: P03277 0.1 mmol/kg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single intravenous bolus injection at 2 mL/sec
Trial: NCT03657264
Drug: NaCl 0.9%
RxNorm normalized name: DEXTROSE 5%/NACL 0.9% INJ
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single intravenous bolus injection at 2 mL/sec
Trial: NCT03657264
Drug: P03277 0.3 mmol/kg
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single intravenous bolus injection at 2 mL/sec
Trial: NCT00880321
Drug: GSK2118436
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Dose escalation with GSK2118436 may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached.
Trial: NCT00636935
Drug: Antibiotics only
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Antibiotic only for treatment for mild (pO2 \> 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
Trial: NCT00636935
Drug: Antibiotics + Corticosteroids
RxNorm normalized name: Antibiotics and corticosteroids
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Prednisone 40mg orally twice daily for 11 days, followed by 40mg once daily for 5 days, followed by 20mg once daily for 5 days and antibiotics (Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone).
Trial: NCT00636935
Drug: Corticosteroids + antibiotics
RxNorm normalized name: Antibiotics and corticosteroids
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Drugs will be prescribed per standard of care for patients with PCP and pO2 \< 70mmHg.
Trial: NCT05840068
Drug: Chemotherapy
RxNorm normalized name: Chemotherapy Glove SML
FDA approved: no
EMA approved: no
PMDA approved: no
Description: The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).
Trial: NCT00880321
Drug: GSK2118436
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Part 2 will use the recommended Part 2 dose of GSK2118436 identified during Part 1 of the study. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2.
Trial: NCT02424552
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Filling material: lactose monohydrate, cellulose, magnesium stearate
Trial: NCT03799913
Drug: Cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: 300mg/m2/d
Trial: NCT00899977
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Matching placebo
Trial: NCT03504735
Drug: Caduet Pill
RxNorm normalized name: Caduet Pill
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Take once daily.
Trial: NCT03504735
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Take once daily.
Trial: NCT02848612
Drug: anticoagulation by unfractionated heparin
FDA approved: no
EMA approved: no
PMDA approved: no
Description: anticoagulation by unfractionated heparin
Trial: NCT00659659
Drug: MEDI-563
RxNorm normalized name: Medi-Lyte
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 100 mg, 200 mg SC
Trial: NCT01116921
Drug: Surfactants, Pulmonary
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Curosurf®, Chiesi USA, Inc., Cary, NC
Trial: NCT03877705
Drug: Listerine ready tabs
RxNorm normalized name: Listerine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Technically, it's a rectangular-shaped, bilayer-compressed tablet that once chewed, creates just enough liquid to swish around your mouth to get a whole-mouth clean feeling.As manufacture claimed the tablet is easy to use just in three simple steps: chew (to activate), swish (to clean), then swallow as unlike mouthwashes which may contain alcohol and other ingredients not intended for ingestion, Listerine Ready Tabs are alcohol-free and safe to swallow which is highly suitable for bedridden patients.
Trial: NCT01544634
Drug: Qvar 50
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Qvar 50, 1 puff bd for 6 weeks
Trial: NCT01544634
Drug: Qvar 100
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Qvar 100, 2 puffs bd for 6 weeks
Trial: NCT00005964
Drug: cyclophosphamide
RxNorm normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Trial: NCT00005964
Drug: doxorubicin hydrochloride
RxNorm normalized name: Doxorubicin Hydrochloride
DrugBank: Doxorubicin (DB00997)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT01898520
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Oromucosal spray containing ethanol: propylene glycol(50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum daily dose was 12 sprays per day.
Trial: NCT04041973
Drug: Artemether-lumefantrine
RxNorm normalized name: artemether-lumefantrine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: One tablet AL contains 20 mg artemether and 120 mg lumefantrine~The prophylaxis will start with a 3-day course of twice daily AL. This will be followed by 2 doses 8 hours apart on one day per week for up to 3 28-35 day consecutive follow-up periods and for 4 weeks after leaving the forest.
Trial: NCT00902811
Drug: AM(FDC)
RxNorm normalized name: Encora AM Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Artesunate-mefloquine fixed dose combination (artesunate 25mg/mefloquine hydrochloride 55mg, or artesunate 100mg/mefloquine hydrochloride 220mg), according to age-group.
Trial: NCT00902811
Drug: AM(LT)
RxNorm normalized name: Encora AM Tablet
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Artesunate (Arsumax®, Sanofi) 50 mg tabs given at 4 mg/Kg/day on day 0, day 1 and day 2 (total 12 mg/Kg) PLUS Mefloquine 250 mg base tabs given at 25 mg/Kg on day 0. Treatment is given in three equally divided daily doses to the nearest quarter tablet.
Trial: NCT00902811
Drug: AA(FDC)
RxNorm normalized name: DYE FDC BLUE #1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Artesunate-amodiaquine fixed dose combination (FDC) (Artesunate Amodiaquine Winthrop® Sanofi Aventis); Artesunate 25mg/amodiaquine 67.5mg; Artesunate 50mg/amodiaquine 135mg ; Artesunate 100mg/amodiaquine 270mg
Trial: NCT03039101
Drug: Placebo Oral Tablet
RxNorm normalized name: placebo ORAL TABLET
FDA approved: no
EMA approved: no
PMDA approved: no
Description: one pill orally, daily, for 1 week
Trial: NCT01228175
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 25mg look alike riboflavin tablets to match active study medication.
Trial: NCT04448431
Drug: Desvenlafaxine
RxNorm normalized name: Desvenlafaxine
DrugBank: Desvenlafaxine (DB06700)
FDA approved: yes
EMA approved: no
PMDA approved: no
Description: 50 mg/day capsules, orally
Trial: NCT00838370
Drug: Capecitabine, 5-fluorouracil
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Patients to treat with capecitabine/5-FU will be screened prior to start of therapy for DPYD\*2A. Patients heterozygous or homozygous mutant for DPYD\*2A receive dose reductions of capecitabine/5-FU of at least 50% in the first two courses. In case this dose is tolerated well, doses will be increased.~In addition, the pharmacokinetics of capecitabine/5-FU and their metabolites will be assessed in these patients.
Trial: NCT03238963
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Once daily
Trial: NCT01614041
Drug: Usual dose treatment of Tandospirone
RxNorm normalized name: OIL OF CAMPHOR
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Usual dose treatment of Tandospirone, oral, 30 mg/day
Trial: NCT01614041
Drug: Comparative high dose of tandospirone treatment
RxNorm normalized name: high-density polyethylene
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Comparative high dose of tandospirone treatment, oral, 60 mg/day
Trial: NCT00798434
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo administered orally in the morning or evening.
Trial: NCT01647945
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: placebo pill
Trial: NCT01647945
Drug: FK506 level < 2 ng/ml
FDA approved: no
EMA approved: no
PMDA approved: no
Description: FK506 goal trough blood level \< 2 ng/ml
Trial: NCT01647945
Drug: FK506 level 2-3 ng/ml
FDA approved: no
EMA approved: no
PMDA approved: no
Description: FK506 goal trough blood level 2-3 ng/ml
Trial: NCT01647945
Drug: FK506 level 3-5 ng/ml
FDA approved: no
EMA approved: no
PMDA approved: no
Description: FK506 goal trough blood level 3-5 ng/ml
Trial: NCT02074904
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02842541
Drug: EBI-031
RxNorm normalized name: ethanol
DrugBank: Ethanol (DB00898)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT03542110
Drug: Matching Placebo subcutaneous injection
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Single-dose, pre-filled, disposable, subcutaneous injection pen
Trial: NCT02502747
Drug: optimal standard of care
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Optimal standard of care
Trial: NCT02960503
Drug: Azithromycin
RxNorm normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
FDA approved: yes
EMA approved: no
PMDA approved: yes
Description: Study participants will be randomized to the treatment arm (azithromycin 500 mg three times a week for 6 months).
Trial: NCT03659162
Drug: Azole Antifungal
RxNorm normalized name: Azole antifungal
FDA approved: no
EMA approved: no
PMDA approved: no
Description: oral gel \& injections
Trial: NCT04395170
Drug: Standard (specific) therapy for COVID-19
RxNorm normalized name: covid-19, protein subunit
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities.~To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.
Trial: NCT01762332
Drug: Base level of remifentanil effect side concentration: 4ng/ml
FDA approved: no
EMA approved: no
PMDA approved: no
Description: constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.
Trial: NCT01156740
Drug: Penicillin G, Benzathine
FDA approved: no
EMA approved: no
PMDA approved: no
Description: IM BPG; 600,000 U \> 27kg or 1,200,000 U \<27 kg)
Trial: NCT00974519
Drug: Fuzheng 3
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Immunity 3 (Fuzheng 3), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.~Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Trial: NCT00974519
Drug: Fuzheng 1
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Immunity 1 (Fuzheng 1), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.~Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Trial: NCT00974519
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.~Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Trial: NCT02271984
Drug: MSC2499550A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each intervention period.
Trial: NCT02271984
Drug: Cysticide
RxNorm normalized name: Crystacide
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
Trial: NCT02271984
Drug: MSC2499550A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
Trial: NCT02271984
Drug: MSC2499550A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
Trial: NCT02271984
Drug: MSC2499550A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
Trial: NCT02271984
Drug: MSC2499550A
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
Trial: NCT03038035
Drug: MLC901
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 24 weeks intervention with orally MLC901. 2 capsules 3 times a day
Trial: NCT03038035
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 24 weeks intervention with orally placebo. 2 capsules 3 times a day
Trial: NCT03289559
Drug: Aromatase Inhibitors
RxNorm normalized name: Aromatase inhibitors
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03289559
Drug: Testosterone gel
RxNorm normalized name: Androgel 1.62% Metered Dose Pump Testosterone Gel
DrugBank: (1,2,6,7-3H)Testosterone (DB14093)
FDA approved: yes
EMA approved: no
PMDA approved: no
Trial: NCT02749097
Drug: SHR0534
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT02749097
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00641680
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT00777075
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Trial: NCT03651557
Drug: Neu2000KWL High-dose group
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1st infusion of 1500mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 750 mg at intervals of 12 hours(Total drug dosage is 5250mg.)
Trial: NCT03651557
Drug: Placebo
RxNorm normalized name: placebo
FDA approved: no
EMA approved: no
PMDA approved: no
Description: 1st infusion of the same volume of saline in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of the same volume of saline at intervals of 12 hours
Trial: NCT03415243
Drug: Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg
RxNorm normalized name: acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Contents of the sachet will be emptied into a glass bottle and 225 mL of hot, but not boiling water (approximately 90-95°C), will be added to the container and mixed to dissolve the contents of the sachet. The dissolved solution will be allowed to cool to approximately 40 - 50 degree Celsius (°C). After cooling, a small volume (1 to 10 microliters \[mcL\]) of 99mTc-DTPA (Technetium-99m-diethylene-triamine-pentaacetate will be added to the drug solution in to achieve a maximum of 108 curie(mcCi) i.e.4 megabecquerel \[MBq\] per individual dose at the time of dosing. The container will be capped and maintained at a temperature between 35-45°C at time of dosing and then participants will be instructed to consume the hot drink entirely within 30 seconds.
Trial: NCT03415243
Drug: Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg
RxNorm normalized name: acetaminophen
DrugBank: Acetaminophen (DB00316)
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Caplet doses will be prepared by drilling hole of approximately(app.)1millimetre(mm)diameter and app.2-2.5mm deep into individual caplets.99mTc-DTPA(dissolved in normal saline)will be added into hole of each caplet as low volume liquid(0.5-2.0mcL)to achieve maximum of 54 mcCi(2MBq)per caplet at time of dosing(2caplets=108 mcCi\[4MBq\]dose per assessment visit).Applied liquid will be allowed to air dry,hole to be filled with equivalent powder blend from crushed caplet so drug content will remain constant for all caplets.Caplet will be sealed with appropriate material.Radiolabeled caplets will be packaged as unit doses(2 caplets per container)and maintained at room temperature until administration.Caplets will be swallowed with 225mL of noncarbonated room temperature water within 30 seconds.
Trial: NCT00078338
Drug: Rebif®
FDA approved: no
EMA approved: no
PMDA approved: no
Description: Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).