scholarly journals Single-Dose and Multiple-Dose Pharmacokinetics and Dose Proportionality of Intravenous and Intramuscular HPβCD-Diclofenac (Dyloject) Compared with Other Diclofenac Formulations

2013 ◽  
Vol 33 (10) ◽  
pp. 1012-1021 ◽  
Author(s):  
Fred Mermelstein ◽  
Douglas A. Hamilton ◽  
Curtis Wright ◽  
Peter G. Lacouture ◽  
Atulkumar Ramaiya ◽  
...  
Keyword(s):  
Single Dose ◽  
Multiple Dose ◽  
Dose Proportionality ◽  
Multiple Dose Pharmacokinetics

Single-Dose and Multiple-Dose Pharmacokinetics of Nicotine 6 mg Gum

2016 ◽  
pp. ntw211
Author(s):  
Anna Hansson ◽  
Thomas Rasmussen ◽  
Holger Kraiczi
Keyword(s):  
Single Dose ◽  
Multiple Dose ◽  
Multiple Dose Pharmacokinetics

Single-dose and multiple-dose pharmacokinetics of etintidine in healthy volunteers

1988 ◽  
Vol 34 (1) ◽  
pp. 101-104 ◽  
Author(s):  
S. -M. Huang ◽  
T. B. Marriott ◽  
H. S. Weintraub ◽  
J. D. Arnold ◽  
J. Boccagno ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Volunteers ◽  
Multiple Dose ◽  
Multiple Dose Pharmacokinetics

Single- and Multiple-Dose Pharmacokinetics and Dose Proportionality of the Psychotropic Agent Paliperidone Extended Release

2009 ◽  
Vol 49 (11) ◽  
pp. 1318-1330 ◽  
Author(s):  
Sandra Boom ◽  
Krishna Talluri ◽  
Luc Janssens ◽  
Bart Remmerie ◽  
Marc De Meulder ◽  
...  
Keyword(s):  
Multiple Dose ◽  
Extended Release ◽  
Dose Proportionality ◽  
Psychotropic Agent ◽  
Multiple Dose Pharmacokinetics ◽  
Paliperidone Extended Release

scholarly journals Single- and Multiple-Dose Pharmacokinetics of Caspofungin in Healthy Men

2002 ◽  
Vol 46 (3) ◽  
pp. 739-745 ◽  
Author(s):  
Julie A. Stone ◽  
Sherry D. Holland ◽  
Peter J. Wickersham ◽  
Andrew Sterrett ◽  
Michael Schwartz ◽  
...  
Keyword(s):  
Single Dose ◽  
Multiple Dose ◽  
Panel Study ◽  
Loading Dose ◽  
Plasma Drug ◽  
Single Dose Study ◽  
Healthy Men ◽  
Drug Concentrations ◽  
Multiple Dose Pharmacokinetics ◽  
Plasma Drug Concentrations

ABSTRACT Caspofungin, a glucan synthesis inhibitor, is being developed as a parenteral antifungal agent. The pharmacokinetics of caspofungin following 1-h intravenous infusions in healthy men was investigated in four phase I studies. In an alternating two-panel (six men each), rising-single-dose study, plasma drug concentrations increased proportionally with the dose following infusions of 5 to 100 mg. The β-phase half-life was 9 to 10 h. The plasma drug clearance rate averaged 10 to 12 ml/min. Renal clearance of unchanged drug was a minor pathway of elimination (∼2% of the dose). Multiple-dose pharmacokinetics were investigated in a 2-week, serial-panel (5 or 6 men per panel) study of doses of 15, 35, and 70 mg administered daily; a 3-week, single-panel (10 men) study of a dose of 70 mg administered daily; and a parallel panel study (8 men) of a dose of 50 mg administered daily with or without a 70-mg loading dose on day 1. Moderate accumulation was observed with daily dosing. The degree of drug accumulation and the time to steady state were somewhat dose dependent. Accumulation averaged 24% at 15 mg daily and ∼50% at 50 and 70 mg daily. Mean plasma drug concentrations were maintained above 1.0 μg/ml, a target selected to exceed the MIC at which 90% of the isolates of the most clinically relevant species of Candida were inhibited, throughout therapy with daily treatments of 70 or 50 mg plus the loading dose, while they fell below the target for the first 2 days of a daily treatment of 50 mg without the loading dose. Caspofungin infused intravenously as a single dose or as multiple doses was generally well tolerated. In conclusion, the pharmacokinetics of caspofungin supports the clinical evaluation of once-daily dosing regimens for efficacy against fungal infections.

Single- and Multiple-Dose Pharmacokinetics of an Oral Mixed Amphetamine Salts Extended-Release Formulation in Adults

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S20) ◽  
pp. 6-15 ◽  
Author(s):  
Susan B. Clausen ◽  
Stephanie C. Read ◽  
Simon J. Tulloch
Keyword(s):  
Multiple Dose ◽  
Extended Release ◽  
Research Unit ◽  
Dose Proportionality ◽  
Open Label ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Clinical Research Unit ◽  
Multiple Dose Pharmacokinetics ◽  
Oral Doses

AbstractObjectives: Assess the bioavailability of mixed amphetamine salts extended-release (MAS XR) 30-mg capsules and the dose proportionality of pharmacokinetic measures for MAS XR 20,40, and 60 mg.Methods: Study A, an open-label single-period study, and Study B, a randomized, open-label, three threeway crossover study, were conducted in healthy adults in a clinical research unit. In Study A, 20 subjects received a single MAS XR 30-mg capsule by mouth daily for 7 days. In Study B, 12 subjects received single oral doses of MAS XR 20,40, and 60 mg separated by 7-14-day washout periods.Findings: Plasma dextroamphetamine (D-amphetamine) and levoamphetamine (L-amphetamine) concentrations were measured using a validated LC-MS/MS method. In Study A, a 3:1 ratio of D-amphetamine to L-amphetamine was observed for AUC0-∞ and Cmax. Tmax was 4.2 and 4.3 hours for D-amphetamine to Lamphetamine, respectively. In Study B, for D- and Lamphetamine, statistically significant differences were observed for AUC0-t, AVC0-∞, and Cmax between all doses; there was a linear relationship between pharmacokinetic variables and dose and Tmax was similar for each isomer (range: 4.5–5.3 hours) with all given MAS XR doses.Conclusion: The extent of exposure as assessed by mean AUC0-24 and Cmax reflected the 3:1 ratio of D-amphetamine to L-amphetamine in MAS XR 30-mg capsules. The pharmacokinetic profiles of MAS XR 20, 40, and 60 mg are dose proportional for the isomers.

Single-Dose and Multiple-Dose Pharmacokinetics and Safety of Telbivudine After Oral Administration in Healthy Chinese Subjects

2006 ◽  
Vol 46 (9) ◽  
pp. 999-1007 ◽  
Author(s):  
Pei Hu ◽  
Ji Jiang ◽  
Hongyun Wang ◽  
Keith Pietropaolo ◽  
George C. Chao ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Administration ◽  
Multiple Dose ◽  
Healthy Chinese ◽  
Multiple Dose Pharmacokinetics ◽  
Chinese Subjects
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