Phase 1 N=40 Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Plasma Concentrations
Primary: Cmax — 34.96; 249.55 pg/mL
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N/A N=64 Effect of Inflammation on Pharmacokinetics of Posaconazole
Mycoses
Primary: C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L — 1.8; 23.5 mg/L — p=0.77
Phase 4 N=30 Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Arrhythmia · Atrial Fibrillation · Atrial Flutter
Primary: Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. — 0.20 Correlation coefficient R
Phase 2 N=15 Human Fibrinogen - Pharmacokinetics
Fibrinogen Deficiency
Primary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001
Phase 4 N=60 Pharmacokinetics of Preoperative Vancomycin
Surgical Site Infection · Vancomycin
Primary: Pharmacokinetics Analysis: V˅c — 2.56; 1.14 L
N/A N=35 Plasma Protein Binding Characteristics of Voriconazole
Focus of the Study:Protein Binding Characteristics of Voriconazole.
Primary: Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations. — 49.1; 49.6 % of plasma protein binding
Phase 1 N=14 Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers
Human Immunodeficiency Virus
Primary: Steady State Plasma Concentrations of Doravirine After Drug Intake Cessation up to 72 Hours Post-dose. — 18354; 26338 ng*hr/mL
N/A N=10 Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
Cystic Fibrosis
Primary: Blood-plasma Concentration of Piperacillin — 21; 21 mg/L
Phase 4 N=12 To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
Infections, Fungal
Primary: Plasma Concentrations of Voriconazole — 839.50; 2182.33 ng/mL
Phase 2 N=56 Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF
Age-related Macular Degeneration · Diabetic Macular Edema · Retinal Vein Occlusion
Primary: Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses — 0.45; 0.76; 0.11; 0.58 nM
Phase 4 N=50 Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease
Liver Disease
Primary: Number of Participants That Reached Targeted International Normalized Ratio (INR) Within ±0.1 After First Fresh Frozen Plasma (FFP) Transfusion Completed. — 7; 17…
Phase 2 N=59 Pharmacokinetics of Advantage Arrest in Children
Dental Caries
Primary: Predicted Peak Serum Silver Concentration (Cmax) — 17.8 ng/ml
N/A N=19 Estimating Blood Concentrations of Anaesthetics During One-Lung Ventilation (OLV)
One-Lung Ventilation
Primary: Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation — 0.0807 Correlation coefficient
Phase 1 N=25 Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809
Healthy
Primary: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) — 421.0; 829; 1840.0; 3300.0 nanomole*hours/Liter (nmol∙h/L)
Phase 1 N=24 Ascending Doses of Autologous FDP vs FFP
Freeze Dried Plasma in Healthy Volunteers
Primary: Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests — 4; 4; 4; 4 Participants
N/A N=10 Volume Kinetics for Starch Solution and Acetated Ringers
Blood Volume · Blood Coagulation
Primary: Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both. — 5.53; 2.94; 3.12; 4 Litre
N/A N=30 Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
Congenital Heart Disease
Primary: Acetaminophen Serum Concentrations — 19; 17; 13; 13 mcg/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
Phase 4 N=195 Dose Response of a Tubule Occlusion Agent
Dentine Hypersensitivity · Dental Pain
Primary: Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15 — -26.1; -28.4; -26.2 Units on a scale — p=0.3628
Phase 1 N=6 Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis
Primary: Cumulative Excretion of Radioactivity — 35.29; 24.26; 0.75; 2.40 Percentage of administered dose
N/A N=65 Beta-lactam Pharmacokinetics in Secondary Care
Pharmacokinetics · Beta Lactam Adverse Reaction · Penicillin Allergy
Primary: Fraction of the Dosing Interval Over Which the Concentration of Unbound Drug is Greater Than the Minimum Inhibitory Concentration (fT>MIC) — 0.457; 0.429; 0.747; 0.417…
Phase 1 N=47 Subcutaneous Pharmacokinetics of Belatacept
Transplantation
Primary: Maximum Observed Serum Concentration (Cmax) of Belatacept — 3.9; 6.2; 8.5; 11.1 ug/mL
Phase 4 N=13 Effect of Valproic Acid Concentration on Photic Response
Photosensitive Epilepsy
Primary: Difference in SPR During Placebo and VPA Infusions — 15.917; 14.609 standard photosensitive range (SPR) — p=0.016
N/A N=16 Concentrations of Raltegravir in the Semen of HIV-Infected Men
HIV
Primary: Seminal Concentrations of Raltegravir. — 0.18; 1.91 mg/l
N/A N=24 Sevoflurane Concentrations in Children
Anesthetic · Sevoflurane · Age
Primary: Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia — 0; 0; 0.684; 0.6615 ratio
Phase 2 N=10 Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid
Pharmacokinetics
Primary: Unbound Ceftolozane Exposure in the Plasma — 322.6 mg*h/L
N/A N=18 An Observational Pharmacokinetic Sudy of Ceftolozane-Tazobactam in Intensive Care Unit in Patients With and Without CRRT
Gram-Negative Bacterial Infections
Primary: Probability of Target Attainment for 40% fT>MIC — 100; 100 percentage of time above MIC
Phase 1 N=21 Tobramycin Tear Concentrations
Dry Eye
Primary: Tobramycin Tear Concentration Cmax (Maximum Concentration) — 853; 527; 542 µg/mL
N/A N=14 Concentrations of Maraviroc in the Semen of HIV-Infected Men
Maraviroc Concentrations in Semen
Primary: Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. — 0.20; 0.16; 0.92; 4.32 Inhibitory concentration ratio
Phase 4 N=8 Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients
Systemic Fungal Infections
Primary: Posaconazole Exposure Described as Area Under the Total Plasma Concentration-time Curve From Time Zero to Infinity After a Single Dose — 17932 ng*h/mL