An Assessment of the Pharmacokinetics and Tolerability of Single-Ascending Doses of Desvenlafaxine Administered to HealthyChinese Subjects
نویسندگان
چکیده
Abbreviations: %CV: Coefficient of Variation; Ae: Amount Excreted; AE: Adverse Event; AUC: Area under the Plasma Concentrationversus-Time Curve; AUC0-∞: Area under the Concentration-time Curve from Time 0 to Infinity; Cl/F: Apparent Oral-Dose Clearance; CLR: Renal Clearance; Cmax: Peak Plasma Concentration; CYP: Cytochrome P450; ECG: Electrocardiogram; LC/MS/MS: Liquid Chromatography/Tandem Mass Spectrometry Detection; LOQ: Limit of Quantitation; Max: Maximum; MDD: Major Depressive Disorder; Min: Minimum; NODV: N,O-didesmethylvenlafaxine; NR: Not Reported; ODV: O-desmethylvenlafaxine; SNRIs: SerotoninNorepinephrine Reuptake Inhibitors; t1/2: Mean Elimination Half-Life; TEAEs: Treatment-Emergent Adverse Events; tmax: Time to Peak Plasma Concentration; Vz/F: Apparent Volume of Distribution Introduction
منابع مشابه
Single and multiple dose pharmacokinetics and tolerability of HX-1171, a novel antioxidant, in healthy volunteers
BACKGROUND HX-1171 (1-O-hexyl-2,3,5-trimethylhydroquinone) is a promising antioxidant with therapeutic potential for hepatic fibrosis. The aim of this study was to investigate the tolerability and pharmacokinetics of HX-1171 in healthy volunteers. METHODS A randomized, single-blind, placebo-controlled, dose escalation study was conducted in 83 subjects. In the single ascending dose study, 20,...
متن کاملPharmacokinetics, pharmacodynamics, and tolerability of LC350189, a novel xanthine oxidase inhibitor, in healthy subjects
INTRODUCTION LC350189 is a novel selective xanthine oxidase inhibitor under clinical development for the management of hyperuricemia in gout patients. The aim of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of the drug in healthy subjects. METHODS A dose-block randomized, double-blind, active and placebo-controlled, single- and multiple-dosing study was ...
متن کاملPhase 1 safety, tolerability, and pharmacokinetic study of single ascending doses of XM17 (recombinant human follicle-stimulating hormone) in downregulated healthy women
BACKGROUND XM17 is a recombinant human follicle-stimulating hormone (follitropin alfa) for stimulation of multifollicular development in women undergoing controlled ovarian hyper-stimulation during assisted reproductive therapy and for treatment of anovulation. Manufactured using Chinese hamster ovary cells transfected with the human follicle-stimulating hormone gene, XM17 has an identical amin...
متن کاملAn assessment of drug-drug interactions: the effect of desvenlafaxine and duloxetine on the pharmacokinetics of the CYP2D6 probe desipramine in healthy subjects.
A number of antidepressants inhibit the activity of the cytochrome P450 2D6 enzyme system, which can lead to drug-drug interactions. Based on its metabolic profile, desvenlafaxine, administered as desvenlafaxine succinate, a new serotonin-norepinephrine reuptake inhibitor, is not expected to have an impact on activity of CYP2D6. This single-center, randomized, open-label, four-period, crossover...
متن کاملInvestigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of a Long-Acting α-MSH Analog in Healthy Overweight and Obese Subjects
MC4-NN2-0453 is a novel, long-acting, selective, melanocortin-4-receptor agonist developed for treatment of obesity. This first-human-dose, randomized, double-blind, placebo-controlled trial investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MC4-NN2-0453 in overweight to obese but otherwise healthy subjects. The trial included a single-...
متن کامل