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Dexferrum Medical Research Studies

Up-to-date List of Dexferrum Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Dexferrum Medical Research Studies

Rank Status Study
1 Recruiting Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women
Condition: Pregnancy
Intervention: Drug: Intravaneous iron(low molecular weight iron dextran)
Outcome Measure: percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(INfeD).
2 Unknown  Intravenous Ferric Carboxymaltose (FCM) Versus IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
Condition: Iron Deficiency Anemia
Interventions: Drug: Ferric Carboxymaltose (FCM);   Drug: Iron Sucrose / Iron Dextran
Outcome Measure: Changes from baseline in markers of oxidative stress (including glutathione peroxidase, malondialdehyde (MDA), ratio of GSH:GSSG, oxidatively modified proteins and lymphocyte analysis).
3 Recruiting Iron Supplementation Using Total Dose Infusion and Oral Routes for Treatment of Iron Deficiency Anemia in Pregnancy
Condition: Treatment of Iron Deficiency Anemia in Pregnancy
Interventions: Drug: Theragran Hematinic;   Drug: low molecular weight iron dextran
Outcome Measures: The proportion of patients who have been successfully treated;   Number of participants with adverse effects
4 Recruiting Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke
Condition: Ischemic Stroke
Intervention: Drug: Huatuo Zaizao Pills
Outcome Measures: modified Rankin Scale;   modified Rankin Scale,NIHSS, Barthel Index, and MMSE
5 Recruiting Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
Condition: Renal Impairment
Intervention: Drug: Nalmefene 18 mg
Outcome Measures: For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf);   For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t);   For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax);   For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax);   For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½);   For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR);   For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F);   For nalmefene: apparent volume of distribution for nalmefene (Vz /F);   For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent;   Safety and tolerability
6 Recruiting The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg
Condition: Epilepsy
Interventions: Drug: Lamotrigine Dispersible/Chewable tablet;   Drug: Lamotrigine Compressed tablet
Outcome Measures: Area under the concentration-time curve [AUC(0-inf)] of lamotrigine if coefficients of variation (CV)% of λz<=30%, or AUC(0-inf)• λz if CV% of λz >30%, or AUC(0-t) if AUC(0-inf) cannot be accurately determined, including bioequivalence evaluation;   The observed maximum serum drug concentration (Cmax), including bioequivalence evaluation;   Time to reach Cmax (Tmax) as data permit.;   Elimination half-time (t1/2) as data permit;   Elimination rate constant, linear regression according to linear serum drug concentration-time curve (λz) as data permit.;   Safety and tolerability as measured by adverse events, vital sign, ECG and clinical laboratory measurements.
7 Recruiting Fed Bioequivalence Study of CBZ Formulations
Conditions: Bio-equivalence Study;   Fed Conditions
Interventions: Drug: Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose;   Drug: Tegretol CR 400 Single Dose-Auration CR 400 Single Dose
Outcome Measures: AUC0-240;   AUC0-inf;   Cmax;   AE
8 Not yet recruiting Bioavailability of Apixaban Crushed Tablet
Condition: Thrombosis
Intervention: Drug: Apixaban
Outcome Measures: Maximum observed plasma concentration (Cmax) of Apixaban;   Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Apixaban;   Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Apixaban;   Safety and tolerability of Apixaban measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of vital signs, ECGs, physical examinations, and clinical laboratory tests;   Cmax of Apixaban;   AUC(INF) of Apixaban;   AUC(0-T) of Apixaban;   Time of maximum observed plasma concentration (Tmax) of Apixaban;   Terminal plasma half-life (T-HALF) of Apixaban;   Relative bioavailability (Frel) of Apixaban
9 Recruiting Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
Condition: Hepatitis C
Intervention: Drug: DCV 3DAA FDC
Outcome Measures: Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325;   Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325;   Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325;   Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325;   Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325;   AUC(0-T) for BMS-794712;   AUC(INF) for BMS-794712;   Cmax for BMS-794712;   Tmax for BMS-794712;   T-HALF for BMS-794712;   Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation;   Safety measured by abnormalities in vital sign measurements;   Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations;   Safety measured by marked abnormalities in clinical laboratory test results
10 Not yet recruiting Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Saxagliptin;   Drug: Dapagliflozin;   Drug: Saxagliptin/Dapagliflozin FDC
Outcome Measures: Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin;   Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)] for Saxagliptin and Dapagliflozin;   Area under the concentration-time curve from time zero extrapolated to infinite time [(AUC(INF)] for Saxagliptin and Dapagliflozin;   Cmax for 5-hydroxy (OH) Saxagliptin;   AUC(0-T) for 5-hydroxy (OH) Saxagliptin;   AUC(INF) for 5-hydroxy (OH) Saxagliptin;   Time of maximum observed plasma concentration (Tmax) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin;   Percent of AUC extrapolated from last quantifiable concentration to infinity (pAUCe) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin;   Half life (T HALF) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin;   Terminal disposition rate constant (Lambda) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin;   Time point where log-linear elimination begins (TLIN) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin;   Time at which the last concentration occurred that is above the lower limit of quantitation (LQCT) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin;   Safety measured by the occurrence of deaths, adverse events (AEs), serious adverse events (SAEs), results of clinical laboratory tests, vital sign measurements, physical examination findings, and 12-lead electrocardiogram (ECG) results
11 Recruiting A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies
Condition: Cancer
Interventions: Drug: GSK1120212B (Standard DMSO content);   Drug: GSK1120212B (Lower DMSO content)
Outcome Measures: Corrected Cmax of GSK1120212B;   Corrected AUC(0-t) and AUC(0-inf) of GSK1120212B;   Corrected tmax of GSK1120212B;   Uncorrected Cmax of GSK1120212B;   Uncorrected AUC(0-t), AUC(0-inf) and AUC(0-24) of GSK1120212B;   Pre-dose concentration (C0) of GSK1120212B;   Elimination half life (t½) of GSK1120212B;   Safety of GSK1120212B as assessed by changes in vital signs measurements;   Safety of GSK1120212B as assessed by changes in clinical laboratory tests;   Safety of GSK1120212B as assessed by number of subjects with adverse events (AE)s
12 Recruiting PK Study of Dapagliflozin in Pediatric Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
Intervention: Drug: Dapagliflozin
Outcome Measures: Maximum observed plasma concentration (Cmax) of Dapagliflozin derived from plasma concentration versus time;   Time of maximum observed plasma concentration (Tmax) of Dapagliflozin derived from plasma concentration versus time;   Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin derived from plasma concentration versus time;   Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin derived from plasma concentration versus time;   Plasma half-life (T-HALF) of Dapagliflozin derived from plasma concentration versus time;   Apparent clearance after extravascular administration (CL/F) of Dapagliflozin derived from plasma concentration versus time;   Apparent volume of distribution at terminal phase after extravascular administration (Vz/F) of Dapagliflozin derived from plasma concentration versus time;   Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs) and clinical laboratory tests;   Maximum observed plasma concentration (Cmax) of Dapagliflozin 3-O-Glucuronide;   Time of maximum observed plasma concentration (Tmax) of Dapagliflozin 3-O-Glucuronide;   Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide;   Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide;   Plasma half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide;   Fasting plasma glucose concentration;   Urinary glucose amounts
13 Recruiting The Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Pediatric Subjects
Condition: Neoplasms, Brain
Interventions: Drug: Dabrafenib 3 mg/kg;   Drug: Dabrafenib 3.75 mg/kg;   Drug: Dabrafenib 4.5 mg/kg;   Drug: Dabrafenib 1.5 mg/kg;   Drug: Dabrafenib 2.25 mg/kg;   Drug: Dabrafenib (Final selected dose from Part 1)
Outcome Measures: Safety and tolerability of dabrafenib as assessed by number of subjects with adverse events (AE)s;   Safety and tolerability of dabrafenib as assessed by change from Baseline in ECG readings;   Safety and tolerability of dabrafenib as assessed by change from Baseline in ECHO findings;   Safety and tolerability of dabrafenib as assessed by change from Baseline in laboratory values;   Safety and tolerability of dabrafenib as assessed by change from Baseline in vital signs;   Maximum concentration (Cmax) of dabrafenib dose(s);   Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-τ)) and AUC from zero to infinity (AUC(0-inf)) of dabrafenib dose(s);   The Cmax of the dosing interval (C trough) of dabrafenib and its metabolites;   The AUC(0-tau) and AUC(0-inf) of dabrafenib and its metabolites;   Apparent clearance following oral dosing (CL/F) of dabrafenib;   The Cmax of dabrafenib , and its metabolites;   Time from administration to Cmax (tmax) of dabrafenib and its metabolites;   Elimination half life (t½) of dabrafenib and its metabolites;   Any preliminary anti-tumor activity of dabrafenib as assessed by number of subjects with AEs;   Any preliminary anti-tumor activity of dabrafenib as assessed by change from Baseline in ECG readings;   Any preliminary anti-tumor activity of dabrafenib as assessed by change from Baseline in laboratory values;   Any preliminary anti-tumor activity of dabrafenib as assessed by change from Baseline in vital signs;   Over all response of dabrafenib;   Effect of age and weight on CL/F of dabrafenib;   Effect of age and weight on volume of distribution (V/F) of dabrafenib;   Effect of age and weight on absorption rate (ka) of dabrafenib;   Effect of age and weight on coefficients for significant covariates of dabrafenib
14 Recruiting Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women
Condition: Healthy
Interventions: Drug: CE/BZA;   Drug: Itraconazole
Outcome Measures: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin.;   Maximum Observed Plasma Concentration (Cmax) for BZA, total estrone adjusted for baseline and total equilin.;   Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.;   Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.;   Apparent Oral Clearance (CL/F) for all analytes.;   Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes.;   Apparent Volume of Distribution (Vz/F) for all analytes.;   Terminal Phase Elimination Half-Life (t1/2) for all analytes.
15 Recruiting Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs. Intravenous Standard of Care for the Treatment of Iron Deficiency Anemia (IDA) in an Infusion Center Setting
Condition: Iron Deficiency Anemia (IDA)
Interventions: Drug: Injectafer;   Drug: iron dextran, ferumoxytol, iron sucrose, sodium ferric gluconate
Outcome Measures: Change from baseline to Day 30 for Short Form Health Survey, 12-Item SF-12v2 quality of life scores;   Change from baseline to Day 30 for Multidimensional Assessment of Fatigue (MAF) scores;   Change from baseline to Day 30 for Work Productivity and Activity Impairment Questionnaire (WPAI) scores;   Treatment Satisfaction Questionnaire for Medication (TSQM) scores on Day 30
16 Recruiting Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Condition: Central Nervous System Lymphoma
Interventions: Drug: Methotrexate;   Drug: Ara-C;   Drug: Rituximab;   Drug: Thiotepa;   Radiation: radiotherapy;   Drug: BCNU;   Other: APBSCT
Outcome Measures: response rate after primary chemotherapy and 2 years failure free survival at second randomization;   safety, as acute and long-term toxicity;   overall survival
17 Recruiting Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Metformin IR;   Drug: Saxagliptin;   Drug: Saxagliptin/Metformin XR FDC;   Drug: Metformin XR
Outcome Measures: Maximum observed plasma concentration (Cmax) of Saxagliptin;   Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin;   Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin;   Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin;   Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin;   Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin;   Maximum observed plasma concentration (Cmax) of Metformin;   Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin;   Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin;   Safety: based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests;   Formulation swallowability of Saxagliptin-Metformin FDC tablet, Glucophage® IR tablet and Glucophage® XR tablet
18 Recruiting Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
Interventions: Drug: TAS-102 with a light tracer dose of [14C]FTD;   Drug: TAS-102 with a light tracer dose of [14C] TPI;   Drug: TAS-102 tablets
Outcome Measures: Urinary, fecal, and respiratory excretion of 14C from FTD and urinary and fecal excretion of 14C from TPI;   PK parameters of total radioactivity (AUC0-inf, AUC0-last, Cmax, Tmax, and T1/2) in whole blood and plasma after a single dose of TAS-102;   Metabolic profile of FTD and TPI in plasma, urine, and feces;   PK parameters of FTD, FTY, and TPI in plasma (Cmax, Tmax, AUC0-last, AUC0-inf, T1/2, CL/F, and Vd/F);   Safety monitoring including adverse events, vital signs, and laboratory assessments;   Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
19 Recruiting Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
Condition: Iron Deficiency Anemia (IDA)
Intervention:
Outcome Measure: Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form).
20 Not yet recruiting Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects
Condition: Psoriasis
Interventions: Drug: MSB0010841 (Anti-IL-17A/F Nanobody);   Drug: Placebo matched to MSB0010841 (Anti-IL-17A/F Nanobody)
Outcome Measures: Number of Subjects With Treatment Emergent Adverse Events (TEAEs);   Number of Subjects With Local Injection Site Reactions (ISRs);   Percentage of Subjects with Anti-MSB0010841 Antibodies (BAbs);   Levels of Pre-existing Anti-MSB0010841 Antibody;   MSB0010841 (Anti-IL-17A/F Nanobody) Serum Concentration;   Pharmacokinetics Profile post First and Third Dose of MSB0010841 (Anti-IL-17A/F Nanobody): AUC (0-t), AUC (0-tau), AUC (0-inf), Cpre, Cmin, Cmax, Cav, MRT (0-tau), MRT (0-inf), tmax, t1/2, lambda_z, CL/f, Vz/f, PTF, Accumulation Ratio of Cmax, and AUC;   Pharmacokinetics Profile Post Second Dose of MSB0010841 (Anti-IL-17A/F Nanobody): Cmax, tmax, Cpre;   Percentage of Subjects With 50 or 75% Improvement in Psoriasis Area and Severity Index (PASI) Score Compared to Baseline;   Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43;   Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at least 2 Level Reduction From Baseline;   Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Days 8, 15, 22, 29, 36, 43, 50, and 85;   Percentage of Subjects with Exacerbation of Psoriasis

These studies may lead to new treatments and are adding insight into Dexferrum etiology and treatment.

A major focus of Dexferrum research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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