Phase 2 N=59 Pharmacokinetics of Advantage Arrest in Children
Dental Caries
Primary: Predicted Peak Serum Silver Concentration (Cmax) — 17.8 ng/ml
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Phase 2 N=143 Evaluate Safety, Efficacy and Pharmacokinetics
Metastatic Breast Cancer
Primary: Area Under the Concentration Time Curve at Steady State (AUCss) — 34400; 31800 ug*h/mL
Phase 4 N=12 Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion
Healthy
Primary: Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose) — 193.33; 165.70 mcg/mL
Early Phase 1 N=7 Pharmacokinetics of Metronidazole Dermal Products
Bioequivalence
Primary: PK Parameters — 283; 341; 189 ng*h/mL
N/A N=15 PK Analysis of Piperacillin in Septic Shock Patients
Septic Shock
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 10 participants
Early Phase 1 N=6 Pharmacokinetic (PK) Analysis of Antitumor B in Patients With Oral Cancer
Squamous Cell Carcinoma of the Oral Cavity
Primary: Area Under the Curve (AUC) for Matrine in Saliva — 4007.9 ng x h/mL
Phase 4 N=79 Meropenem Dosage Strategy Based on PPK Model
Lower Respiratory Tract Infection
Primary: Clinical Success Rate — 28; 35 participants
Phase 3 N=38 Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
Primary Immune Deficiency Disorders · Common Variable Immunodeficiency · X-linked Agammaglobulinaemia
Primary: Data (Derived From Absolute Concentration) Were Pooled With Historical Data and a Treatment Variable Defined (Subgam-VF or Gammaplex 5% IGIV). Outcome Measure Defined as…
Phase 2 N=36 Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration
Rheumatoid Arthritis
Primary: Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX — 118.14; 122.63; 116.71 ng*hr/mL/mg
N/A N=22 Piperacillin PK Analysis in Severe Sepsis Patients
Sepsis · Severe Sepsis
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 4 participants
Phase 4 N=21 Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease
Pompe Disease · Glycogen Storage Disease Type II (GSD II)
Primary: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Alglucosidase Alfa — 204000; 307000 nanograms per milliliter (ng/mL)
Phase 4 N=7 Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Hemoglobinuria, Paroxysmal
Primary: Peak And Trough Concentrations Of Eculizumab In Serum At Week 12 — 192.5; 425.4 μg/mL
Phase 2 N=24 Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
Asthma
Primary: Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine — 9.3; 8.9; 7.8 pg/mL
Phase 1 N=42 Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
Renal Insufficiency
Primary: The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12). — 157.8; 276.5; 415.3 hour*nanogram/milliliter
Phase 1 N=141 A PK Study Comparing MB05, EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.
Healthy Volunteers
Primary: Comparison of the Pharmacokinetic (PK) Profiles Between MB05 and EU-Synagis®, Between MB05 and US-Synagis® and Between EU-Synagis® and US-Synagis® in Terms of Area Under…
N/A N=30 The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
Endometritis
Primary: Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration — 0; 0; 0 number of participants
Phase 3 N=372 PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
Primary: Analysis of Serum AUC0-last of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA) — 162414.81; 167309.07; 172450.97 h*μg/mL
Phase 1 N=18 Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
Healthy Volunteers
Primary: Area Under the Concentration-Time Curve (AUC 0-t) — 1490.0; 1273.0 h*ng/mL
Phase 1 N=41 PK Study With Pantoprazole in Obese Children and Adolescents
Gastroesophageal Reflux Disease
Primary: Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax). — 4.27; 4.1 mcg/ml
Phase 4 N=20 PD and PK Profiles of Switching Between Cangrelor and Ticagrelor Following Ticagrelor Pre-treatment
Coronary Artery Disease
Primary: Platelet Reactivity Measured by VerifyNow — 16.9; 12.6 P2Y12 reaction units
N/A N=12 Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
Coronary Artery Disease · Coronary Artery Stenosis · Coronary Disease
Primary: Maximum Concentration (Cmax) — 2.397 nanograms per milliliter
Phase 1 N=18 Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine
Healthy Volunteers
Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg — 32775 ng*hr/mL
Phase 2 N=30 Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Head and Neck Cancer
Primary: Maximum Plasma Concentration of Zalutumumab After Fourth Infusion — 104.3; 258.1; 494.3 mg/L
Phase 1 N=16 Eletriptan Pharmacokinetics In Korean Males
Healthy
Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] — 291.3; 575.6; 1282.0; 1278.0 ng* hr/mL
Phase 1 N=49 Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function
Long QT Syndrome
Primary: PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine — 42503.2; 50064.7; 57795.9; 39173.2 h*ng/mL
Phase 1 N=17 Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Hepatic Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332 — 1.886; 1.923 micrograms per milliliter (ug/mL)
Phase 1 N=56 Dose-finding Pharmacokinetic Study in Healthy Males
Healthy Volunteers
Primary: Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24) — 4300; 5423; 7439; 9046 h*ng/ml
Phase 1 N=46 A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Parkinson Disease
Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched…
Phase 1 N=30 Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
Peritoneal Dialysis (PD) · Anemia · Chronic Kidney Disease
Primary: Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal…
Phase 1 N=54 Staccato Prochlorperazine Single Dose PK Study
Migraine
Primary: Time to Peak (Tmax) — 0.042; 0.033; 0.025; 0.033 hours