A Single-Dose, Three-Period, Six-Sequence Crossover Study Comparing the Bioavailability Study of Dextromethorphan Hydrobromide Sustained Release (SR) Tablet and the Immediate Release (IR) Tablet in Healthy Volunteers Under Fasting Condition

2015 ◽  
Vol 15 (2) ◽  
pp. 102-105
Author(s):  
Socorrina Colaco ◽  
N. Ramesh ◽  
Sekar Rajan ◽  
Subramania Nainar Meyyanatha
Keyword(s):  
Single Dose ◽  
Sustained Release ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Immediate Release ◽  
Fasting Condition ◽  
Bioavailability Study ◽  
Dextromethorphan Hydrobromide

scholarly journals 81 Bioequivalence of a Manipulation-Resistant Immediate-Release Amphetamine Sulfate Formulation Compared with Reference Standard

CNS Spectrums ◽  
2019 ◽  
Vol 24 (1) ◽  
pp. 216-216
Author(s):  
Steve Caras ◽  
Terrilyn Sharpe
Keyword(s):  
Single Dose ◽  
Healthy Volunteers ◽  
Peak Concentration ◽  
Immediate Release ◽  
Open Label ◽  
Time Curve ◽  
Time To Peak ◽  
Amphetamine Sulfate ◽  
Quantifiable Concentration ◽  
Funding Acknowledgements

AbstractStudy ObjectivesWe compared the bioavailability of racemic amphetamine (d-amphetamine and l-amphetamine) from a manipulation-resistant immediate-release (IR) amphetamine sulfate capsule (AR19) versus amphetamine sulfate IR tablets (reference).MethodIn this open-label, randomized, two-period, two-treatment, two-sequence, crossover study, 36 healthy volunteers aged 18–45 received a single dose (20-mg capsule) of AR19 in one period and a single dose (2 x 10-mg tablets) of reference in another period, after a 10-hour overnight fast. Each drug administration was separated by a washout period of at least 6days. Bioequivalence for d- and l-amphetamine was assessed using time to peak concentration (Tmax), peak concentration in plasma (Cmax), and area under the plasma concentration–time curve from time-zero to the time of the last quantifiable concentration (AUClast) and extrapolated to infinity (AUCinf).ResultsAll 36 volunteers completed both treatment sequences. Mean (standard deviation; SD) Tmax for d- and l-amphetamine was similar for AR19 (2.84[1.05]; 3.05[1.22], respectively) and reference (2.52[0.75]; 2.75[1.00], respectively). The geometric least-squares mean ratios and 90% confidence intervals were within the boundary of 80%–125% for bioequivalence for Cmax (d-amphetamine, 98.35% [96.12–100.64]; l-amphetamine, 98.82% [96.42–101.28]), AUClast (d-amphetamine, 99.45% [96.92–102.05]; l-amphetamine, 99.29% [96.55–102.10]), and AUCinf (d-amphetamine, 99.50%[96.77–102.30]; l-amphetamine, 99.23% [96.06–102.50]). A total of 13 mild adverse events were reported by 7 volunteers (AEs; AR19, n=5; reference, n=8). No serious AEs were reported.ConclusionAR19 was well tolerated and was bioequivalent to reference when administered as a 20-mg dose in healthy volunteers.Funding Acknowledgements: This study was funded by Arbor Pharmaceuticals, LLC.

Influence of food on the oral bioavailability of rupatadine tablets in healthy volunteers: A single-dose, randomized, open-label, two-way crossover study

2007 ◽  
Vol 29 (5) ◽  
pp. 900-908 ◽  
Author(s):  
Anna Solans ◽  
Marcel·lí Carbó ◽  
Juana Peña ◽  
Teresa Nadal ◽  
Iñaki Izquierdo ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Oral Bioavailability ◽  
Open Label ◽  
Influence Of Food
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