An open-label, randomized, single-dose, dose-proportionality study of oral doses of a sustained-release formulation of desvenlafaxine succinate in healthy subjects

2005 ◽  
Vol 77 (2) ◽  
pp. P82-P82 ◽  
Author(s):  
J BEHRLE ◽  
A NICHOLS ◽  
S MCGRORY ◽  
D RAIBLE
Keyword(s):  
Single Dose ◽  
Sustained Release ◽  
Healthy Subjects ◽  
Dose Proportionality ◽  
Open Label ◽  
Release Formulation ◽  
Sustained Release Formulation ◽  
Oral Doses

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.

An Assessment of the Pharmacokinetics of a Sustained-release Formulation of a Tramadol/Acetaminophen Combination in Healthy Subjects

2015 ◽  
Vol 37 (2) ◽  
pp. 376-389 ◽  
Author(s):  
Yong-Jin Im ◽  
Ji-Young Jeon ◽  
Eun-Young Kim ◽  
Yunjeong Kim ◽  
Dong-Joon Oh ◽  
...  
Keyword(s):  
Sustained Release ◽  
Healthy Subjects ◽  
Release Formulation ◽  
Sustained Release Formulation
Sign in / Sign up

Export Citation Format

Share Document