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 1 N=30 Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
Epilepsy
Primary: Maximum Drug Concentration (Cmax) — 9469; 9867; 15067; 17309 ng/mL
Phase 1 N=24 Sensitivity of Pharmacokinetics to Differences in Aerodynamic Particle Size Distribution
Asthma
Primary: Area Under the Plasma Concentration-time Profile From Time 0 the Last Quantifiable Concentration (AUC0-last) With Dose Normalization — 658; 700; 716; 748 pg.h/mL…
N/A N=21 Pharmacokinetics of Ketamine in Infants and Children
The Pk of IV Ketamine in Children With Heart Disease
Primary: Total Clearance and Intercompartmental Clearance — 60.0; 70.8 L/h/70kg
Phase 2 N=59 Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
Intubated and Mechanically Ventilated Pediatric Subjects
Primary: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) — 2681.332; 6460.576; 16992.540; 28531.864 picograms*hr/mL
Phase 2 N=66 Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Healthy Volunteers · Brain Lesion
Primary: Pharmacokinetic (PK) Parameter Cmax — 248.7; 524.5; 698.7; 992.0 µg/mL
Phase 1 N=36 Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
Healthy
Primary: Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) — 281.05; 485.48; 410.46 ng*h/mL
N/A N=60 Propofol Pharmacokinetics and Pharmacodynamics Modelling
Intravenous Anesthetic Agent Overdose
Primary: Plasma Propofol Concentration (mcg/mL) — 2.36; 3.12; 2.91 mcg/mL
Phase 4 N=77 Pharmacodynamic and Pharmacokinetic of Switching From Cangrelor to Prasugrel in ACS Patients Undergoing PCI
Coronary Artery Disease · Acute Coronary Syndrome
Primary: Platelet Reactivity Measured by VerifyNow — 23; 153; 65 PRU
N/A N=107 Pharmacokinetics of Daunorubicin in Young Patients With Cancer
Unspecified Childhood Solid Tumor, Protocol Specific
Primary: Population Estimates for Daunorubicin Hydrochloride Clearance — 116 L/m2/hr
Early Phase 1 N=7 Pharmacokinetics of Metronidazole Dermal Products
Bioequivalence
Primary: PK Parameters — 283; 341; 189 ng*h/mL
Phase 1 N=40 Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
Diabetes Mellitus, Type 2
Primary: AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity) — 10500; 12400; 12600; 17500 nmol*h/L
Phase 1 N=23 Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline — -0.031; -0.055; -0.071; 0.143 ml/min
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 2 N=21 Viral Dynamics and Pharmacokinetics of Abacavir and Tenofovir
HIV Infections
Primary: Change in Short-term Virologic Response — -.11; -.15; -.16; -.16 log(10) copies/mL per day
Phase 3 N=30 Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
Late Effects of Surgery · Staphylococcus Aureus · Surgical Site Infection
Primary: Mean Daptomycin Concentrations at 12, 18, 24, and 48 h — 22.7; 16.2; 12.0; 3.5 mcg/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
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
Phase 1 N=48 Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
Healthy
Primary: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72) — 248; 251; 266; 264 nmol*h/L
Phase 1 N=27 Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects
Kidney Failure, Chronic
Primary: Pharmacokinetic Parameter Cmax of Ticagrelor — 560.32; 598.35; 370.76 ng/mL
Phase 2 N=35 Pharmacokinetics of Oral CK-1827452 in Patients With Stable Heart Failure
Heart Failure
Primary: C Max (Day 1, Dose 1) — 58; 243; 209 ng/mL
Phase 4 N=60 Pharmacokinetics of Preoperative Vancomycin
Surgical Site Infection · Vancomycin
Primary: Pharmacokinetics Analysis: V˅c — 2.56; 1.14 L
Phase 2 N=16 Pharmacokinetics of Advantage Arrest
Dental Caries
Primary: Observed Fluoride Urinary Recovery — 1.29 mg
Phase 1 N=48 Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants
Pharmacokinetics and Pharmacodynamics
Primary: Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter — 55.28; 114.08; 246.00; NA ng/mL
Phase 3 N=13 A Pharmacokinetic Substudy of the TDE-PH-304 Protocol
Pulmonary Arterial Hypertension
Primary: To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen…
Phase 2 N=82 Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
Prostate Cancer
Primary: Time to Meet Insufficient Testosterone Response — 14; 77; 98; 28 days — p=<0.001
Phase 2 N=15 Human Fibrinogen - Pharmacokinetics
Fibrinogen Deficiency
Primary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001
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 1 N=24 Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects
Parkinson Disease
Primary: Cmax - Maximum Plasma Concentration — 407.4; 391.1; 439.6; 382.0 ng/mL