Pharmacokinetic study of two extended-release formulations of cilostazol in healthy Korean subjects: A randomized, open-label, multiple-dose, two-period crossover study

2019 ◽  
Vol 57 (08) ◽  
pp. 408-415
Author(s):  
Wonsuk Shin ◽  
Min-Kyoung Kim ◽  
Doo-Yeoun Cho
Keyword(s):  
Crossover Study ◽  
Pharmacokinetic Study ◽  
Multiple Dose ◽  
Extended Release ◽  
Open Label ◽  
Extended Release Formulations

Pharmacokinetics and Safety of Coadministered Oseltamivir and Rimantadine in Healthy Volunteers: An Open-Label, Multiple-Dose, Randomized, Crossover Study

2012 ◽  
Vol 52 (8) ◽  
pp. 1255-1264 ◽  
Author(s):  
Georgina Cirrincione-Dall ◽  
Barbara J. Brennan ◽  
Rosa M. Ballester-Sanchis ◽  
Mercidita T. Navarro ◽  
Brian E. Davies
Keyword(s):  
Crossover Study ◽  
Healthy Volunteers ◽  
Multiple Dose ◽  
Open Label ◽  
Randomized Crossover Study

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.

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