TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05086666
Drug: AZD4547
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Phase 1b study, subjects will receive continuous twice daily dosing in 21-day cycles (no matter if missed doses or delays exist), with pre-set dose cohorts of 80 mg BID and 120 mg BID.~In Phase 2, subjects will receive continuous twice daily dosing in 21-day cycles with the RP2D or other doses as determined by the investigator and sponsor.
Study: NCT05691621
Drug: Standard Reagents, Whole Blood
Approvals — FDA: no, EMA: no, PMDA: no
Description: All patients receive standard treatment, only their blood and urine samples are needed
Study: NCT05189288
Drug: D418 Tab.
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1T
Study: NCT05189288
Drug: CKD-388 Tab.
Approvals — FDA: no, EMA: no, PMDA: no
Description: 1T
Study: NCT04804371
Drug: F18-FDG
Normalized name: fluorodeoxyglucose F18
Approvals — FDA: no, EMA: no, PMDA: no
Description: Evaluate FDG uptake
Study: NCT00002379
Drug: Levocarnitine
Normalized name: Levocarnitine
DrugBank: Levocarnitine (DB00583)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT06599619
Drug: Single agent, adjuvant anti-PD1 therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: One of the following Single-agent, adjuvant anti-PD1 therapies:~Nivolumab is a type of targeted therapy drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. It works by keeping cancer cells from suppressing the immune system.~Dose = 240 mg IV every 2 weeks/480 mg every 4 weeks or, Pembrolizumab is a monoclonal antibody and a type of immune checkpoint inhibitor that's used in cancer immunotherapy. It works by attaching to the PD-1 protein on the surface of T cells, which are immune cells. This prevents cancer cells from suppressing the immune system, allowing the immune system to attack and kill the cancer cells.~Dose = 200 mg IV every 3 weeks/ 400 mg every 6 weeks
Study: NCT04441073
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
Study: NCT04265053
Drug: Indomethacin 25 MG/50 MG
Normalized name: Indomethacin
DrugBank: Indomethacin (DB00328)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Indomethacin is a nonsteroidal anti-inflammatory drug commonly used to reduce fever, pain, stiffness, and swelling from inflammation. It prevents the production of prostaglandins, endogenous signaling molecules known to cause symptoms from inflammation. We will use Indomethacin to test COX as a potential mechanism explaining sex differences in CBF control. Indomethacin usage is IND exempt.
Study: NCT04265053
Drug: Placebo - Lactose
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subjects will be screened for lactose intolerance. Total dosing will be calculated to match the mg needed for the indomethacin study visit. Placebo usage is IND exempt.
Study: NCT04265053
Drug: Testosterone Transdermal Product
Normalized name: testosterone Transdermal Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Aim 3, males receive this for 7-9 days of the ganirelix treatment.
Study: NCT04265053
Drug: Estradiol Topical
Normalized name: estradiol topical
Approvals — FDA: no, EMA: no, PMDA: no
Description: In Aim 3, females receive this for 7-9 days of the ganirelix treatment.
Study: NCT06576921
Drug: Placebo combined with Chemotherapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo (Dosage form: Lyophilized powder; Unit dose strength: 4.5 mg; Route of administration: IV infusion; Storage requirements: 2-8℃. Protect from light and freezing.) Nap-paclitaxel (Dosage form: Lyophilized powder; Unit dose strength: 100 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) S-1 (Dosage form: Capsule; Unit dose strength: 20 mg; Route of administration: Oral; Storage requirements: 20-30℃. Protect from light.) Oxaliplatin (Dosage form: Lyophilized powder; Unit dose strength: 50 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) Surgery: All surgical procedures are performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer.
Study: NCT04893993
Drug: Thiamine
Normalized name: Thiamine
DrugBank: Thiamine (DB00152)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Tablets. 300mg/tablet. Dosage depends on gender and weight
Study: NCT04893993
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Tablets. Same number of tablets as Thiamine
Study: NCT05984147
Drug: AUR108
Approvals — FDA: no, EMA: no, PMDA: no
Description: 3 Days dosing, and 4 days no dose in a week
Study: NCT05022927
Drug: ERY974
Approvals — FDA: no, EMA: no, PMDA: no
Description: ERY974 vial
Study: NCT05132595
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20ml/h normal saline until starting skin suture.
Study: NCT05073835
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT06454240
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pharmaceutical form:solution for injection-Route of administration:subcutaneous
Study: NCT06367426
Drug: DDN-A-0101 (MAD)
Normalized name: ethanol
DrugBank: Ethanol (DB00898)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Investigational drug~* Development name: DDN-A-0101~* Main ingredient and content: DDN-A-0101 (Houttuynia cordata dry extract, 150.0 mg)~* Formulation and properties: Light brown circular film coating tablet~* Storage method: airtight container, stored at room temperature (1-30 degree celsius)~* Administration method: repeated oral administration (150, 300, 450, 600 mg, 2 times/day, 2 weeks of repeated administration)~* Expiration date: 36 months from the date of manufacture
Study: NCT06367426
Drug: Placebo (SAD)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo drug~* Development name: placebo of DDN-A-0101~* Formulation and properties: Light brown circular film coating tablet~* Storage method: airtight container, stored at room temperature (1-30 degree celsius)~* Administration method: single dose oral administration (300, 600, 900, 1200, 1500 mg)~* Expiration date: 36 months from the date of manufacture
Study: NCT06367426
Drug: Placebo (MAD)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo drug~* Development name: placebo of DDN-A-0101~* Formulation and properties: Light brown circular film coating tablet~* Storage method: airtight container, stored at room temperature (1-30 degree celsius)~* Administration method: repeated oral administration (150, 300, 450, 600 mg, 2 times/day, 2 weeks of repeated administration)~* Expiration date: 36 months from the date of manufacture
Study: NCT05132595
Drug: Ketorolac at high dose
Normalized name: ketorolac Metered Dose Nasal Spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: After the induction of anesthesia, Ketorolac is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h Ketorolac until starting skin suture.
Study: NCT05132595
Drug: Ketorolac at low dose
Normalized name: ketorolac Metered Dose Nasal Spray
Approvals — FDA: no, EMA: no, PMDA: no
Description: After the induction of anesthesia, Ketorolac is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h Ketorolac until starting skin suture.
Study: NCT06416969
Drug: Epinephrine
Normalized name: Epinephrine
DrugBank: Epinephrine (DB00668)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Intravenous infusion
Study: NCT05198323
Drug: LT3001 Drug Product
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered by intravenous infusion
Study: NCT05198323
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered by intravenous infusion
Study: NCT06645821
Drug: EVO101
Approvals — FDA: no, EMA: no, PMDA: no
Description: EVO101 topical cream 0.1%
Study: NCT06326281
Drug: Control group
Normalized name: meningococcal group B vaccine Prefilled Syringe [Trumenba]
Approvals — FDA: no, EMA: no, PMDA: no
Description: All patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) patient controlled analgesias were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours
Study: NCT02127736
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT05995249
Drug: Erythromycin
Normalized name: Erythromycin
DrugBank: Erythromycin (DB00199)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Erythromycin tablets
Study: NCT05995249
Drug: Phenytoin
Normalized name: Phenytoin
DrugBank: Phenytoin (DB00252)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Phenytoin capsules
Study: NCT05602129
Drug: HSK36273
Approvals — FDA: no, EMA: no, PMDA: no
Description: HSK36273
Study: NCT05602129
Drug: Heparin sodium
Normalized name: Heparin Sodium
DrugBank: Heparin (DB01109)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Heparin sodium
Study: NCT05342428
Drug: TLL018 tablets
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral tablets administered at different doses BID daily for 12 weeks.
Study: NCT05887479
Drug: %0,9 NaCl
Approvals — FDA: no, EMA: no, PMDA: no
Description: %0,9 NaCl
Study: NCT06181786
Drug: IMB-101
Approvals — FDA: no, EMA: no, PMDA: no
Description: Intravenous administration.
Study: NCT06181786
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching-placebo intravenous administration.
Study: NCT05649943
Drug: APA + ADT
Approvals — FDA: no, EMA: no, PMDA: no
Description: All participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily. Apalutamide is distributed in Italy under the trade name of Erleada® 60 mg.~All patients not undergoing surgical castration should also continue medical castration by taking a gonadotropin-releasing hormone (GnRHa) analogue during treatment.
Study: NCT05329727
Drug: Angiotensin receptor neprilysin inhibitor (ARNI)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The group with ARNI was defined as patients with HFrEF took ARNI more than 3 months
Study: NCT05329727
Drug: Renin-Angiotensin System Inhibitor (RAS inhibitor)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The group with RAS inhibitor was defined as patients with HFrEF took RAS inhibitor more than 3 months
Study: NCT06474650
Drug: LPM3770164 sustained release tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single-dose of 30 mg of LPM3770164 sustained release tablet
Study: NCT04544943
Drug: BioLexa- Cohort 1
Normalized name: BIOLEX
Approvals — FDA: no, EMA: no, PMDA: no
Description: Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects
Study: NCT04544943
Drug: BioLexa- Cohort 2
Normalized name: BIOLEX
Approvals — FDA: no, EMA: no, PMDA: no
Description: Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients
Study: NCT04544943
Drug: Gentamicin
Normalized name: Gentamicin
DrugBank: Gentamicin (DB00798)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Twice daily (BID) application of Gentamicin for 14 days
Study: NCT05029609
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The placebo nasal solution is the acetate buffer vehicle used for foralumab nasal solution. It will be handled in a manner identical to active drug.
Study: NCT05192382
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo, tablets, once daily by mouth
Study: NCT05776004
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Physiological 0.9% sodium chloride solution for iv administration
Study: NCT04601883
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Encapsulated placebo tablets. Placebo is identical to the active intervention.
Study: NCT06235697
Drug: ADT
Normalized name: Radtue
Approvals — FDA: no, EMA: no, PMDA: no
Description: Assigned at enrollment
Study: NCT05761704
Drug: Novel oral anticoagulant
Normalized name: CPDA-1 Anticoagulant
Approvals — FDA: no, EMA: no, PMDA: no
Description: Conventional dose NOAC for 4 weeks post-LAAC; followed by aspirin/clopidogrel for 4-24 weeks post-LAAC; recommended long-term aspirin treatment after 24 weeks (clopidogrel can be used instead if aspirin is intolerant).
Study: NCT05859763
Drug: 99mTc-HFAPI
Approvals — FDA: no, EMA: no, PMDA: no
Description: Each patient receive a intravenous injection of 99mTc-HFAPI, and undergo SPECT/CT scan within specified time.
Study: NCT04964583
Drug: Hydroxychloroquine with Azithromycin
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.
Study: NCT06320353
Drug: Keytruda®
Approvals — FDA: no, EMA: no, PMDA: no
Description: 100 mg/4 mL (25 mg/mL) concentrate for solution for infusions in a single-dose vial~The required volume (8 ml) of the Drug concentrate solution should be withdrawn from the vials and transferred into an intravenous bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection. (The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.)
Study: NCT06084533
Drug: [11C]-CS1P1
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a single intravenous bolus injection of 10.0 - 20.0 milliCurie (mCi) of the investigational radiotracer \[11C\]-CS1P1. Participants will then undergo a \[11C\]-CS1P1 PET scan.
Study: NCT05521152
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo
Study: NCT06266611
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
Study: NCT04849533
Drug: corticosteroids
Normalized name: CORTICOSTEROIDS
Approvals — FDA: no, EMA: no, PMDA: no
Description: belatacept with chronic steroids is approved regimen for prevention of rejection
Study: NCT05229653
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants in this arm will receive intravenously (IV) matching equal dose of placebo while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver equal volume saline over at least 30 minutes.
Study: NCT06497504
Drug: Bepirovirsen
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bepirovirsen will be administered.
Study: NCT06497504
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo will be administered.
Study: NCT04825496
Drug: Cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Cyclophosphamide is used for lymphodepletion.
Study: NCT05278494
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: PO
Study: NCT06319872
Drug: Oral disulfiram
Normalized name: Disulfiram
DrugBank: Disulfiram (DB00822)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 250 mg/day
Study: NCT05292976
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
Study: NCT06274151
Drug: Naproxen 500 Mg
Normalized name: naproxen 500 MG
DrugBank: Naproxen (DB00788)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Attenuating the sub-acute inflammatory processes to monitor potential beneficial tissue healing following a muscle strain injury
Study: NCT06274151
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sub-acute inflammatory processes not attenuated. Group will be treated as control to monitor tissue healing following a muscle strain injury without pharmacological intervention.
Study: NCT05699876
Drug: Melatonin 6 MG
Normalized name: melatonin 6 MG
DrugBank: Melatonin (DB01065)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: melatonin will be administered orally preoperatively as premedication
Study: NCT05543681
Drug: IGC-AD1-Placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A non-sterile solution for oral administration similar in color and texture to the Active.
Study: NCT06643637
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capsule with no active ingredients
Study: NCT05050500
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: patients meeting the inclusion criteria will be randomized to receive a placebo tablet every 24 hours for 6 months.
Study: NCT04235816
Drug: Azithromycin
Normalized name: Azithromycin
DrugBank: Azithromycin (DB00207)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Administration of azithromycin during the first 15 months of life through the Expanded Program on Immunisation
Study: NCT04235816
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administration of placebo during the first 15 months of life through the Expanded Program on Immunisation
Study: NCT04864145
Drug: Medical therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.
Study: NCT06121726
Drug: Local anesthetic
Normalized name: Local anesthetic
Approvals — FDA: no, EMA: no, PMDA: no
Description: Given the observational nature of the study dose and drugs will be decided by the attending anesthesiologist
Study: NCT04895488
Drug: Usual Antipsychotic Treatment
Approvals — FDA: no, EMA: no, PMDA: no
Description: Second treatment phase. Usual antipsychotic treatment for 26 weeks: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
Study: NCT04940689
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The patient will be anesthetized with morphin.
Study: NCT05619770
Drug: 101-PGC-005
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days
Study: NCT01194193
Drug: AZD8055
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral tablet, single dose on Day 1, followed by a 48 hour - 7 day washout and then either twice daily alternate days dosing from multiple dose day 1 onwards or twice daily dosing for 21 days from multiple dose day 1 onwards followed by 7 days no treatment. Cycles of 28 days.
Study: NCT05576428
Drug: NAC with diet and exercise
Approvals — FDA: no, EMA: no, PMDA: no
Description: NAC with diet and exercise in patients of NAFLD
Study: NCT04675086
Drug: Antiviral Agents
Approvals — FDA: no, EMA: no, PMDA: no
Description: a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization
Study: NCT04926506
Drug: Xiyanping injection
Normalized name: hydrocortisone
DrugBank: Hydrocortisone succinate (DB14545)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid
Study: NCT05487794
Drug: Testosterone Cypionate 100 MG/ML
Normalized name: testosterone cypionate 100 MG/ML
Approvals — FDA: no, EMA: no, PMDA: no
Description: Testosterone is also responsible for increasing hematocrit by stimulating erythropoiesis (Velho et al., 2017). In cisgender men, who are hypogonadal and do not adequately produce testosterone, treatment with the use of testosterone is associated with stimulation of erythropoiesis, which can potentially increase blood viscosity, resulting in secondary erythrocytosis (Hajjar et al., 1997).
Study: NCT06384235
Drug: LTC004
Approvals — FDA: no, EMA: no, PMDA: no
Description: LTC004,45μg/kg,IV,Day 1,Q3W;
Study: NCT06396013
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Basic treatment: According to the recommendations of the Guidelines, all participant took the traditional Chinese medicine decoction Huoxue Sanyu Decoction orally. 2 times/day for 12 weeks.~Acute administration: When the participant has unbearable itching, the doctor can give loratadine tablet 10mg orally once a night, and record the dosage and frequency of use.
Study: NCT05821075
Drug: Prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: prednisolone 60mg tablet once daily for 5 days then tapering dose
Study: NCT04559646
Drug: Haemostatic solution Haemoblock application
Normalized name: collagen hemostat
Approvals — FDA: no, EMA: no, PMDA: no
Description: Haemostatic solution Haemoblock will be used after pocket formation during pacemaker implantation.
Study: NCT05464030
Drug: Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine will be administered orally as per standard of care.
Study: NCT05112159
Drug: placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching placebo tablets to IPG1094 50mg and 100mg
Study: NCT06080165
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: matching placebo
Study: NCT05807971
Drug: ATH-063
Approvals — FDA: no, EMA: no, PMDA: no
Description: 12.5 and 50 mg Capsules, anticipated dose range to be from 25 to 250 mg.
Study: NCT05807971
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Identical capsule to the drug without the active ingredient.
Study: NCT06359197
Drug: Caffeine Pill
Normalized name: caffeine Pill
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants would take two Wake-Ups 200mg Caffeine tablets to meet the target dose of 400mg of caffeine. These are a registered natural health product with Health Canada (NPN 80003474). They are developed by Adrem Brands, which was established in 1951. Quality control testing is performed at a third-party independent lab, Nucro-Technics, which is audited by Health Canada and the US FDA. This ensures that the caffeine tablets comply with Health Canada standards. The tablets contain caffeine anhydrous-a processed, dehydrated form of caffeine-which allows for a standard dose per tablet. The tablets are sugar-free, which reduces the confounding effect of sugar on our results; thus, the investigators can be more confident that the obtained results are reflective of the association between caffeine and the CVD-related protein biomarkers.