International Scholarly Research Notices / 2012 / Article / Tab 4

Research Article

Application of a Reliable LC-MS/MS Method for Determination of Rizatriptan in Healthy Subject Samples: Demonstration of Assay Reproducibility by Incurred Sample Reanalysis

Table 4

(a) Mean pharmacokinetic parameters after oral administration of 10 mg rizatriptan orally disintegrating tablet formulation to 40 and 32 healthy Indian subjects under fasting and fed conditions, respectively. (b) Comparison of treatment ratios and 90% CIs of natural log- (Ln-) transformed parameters for test and reference 10 mg orally disintegrating tablet formulations of rizatriptan in 40 and 32 healthy Indian subjects under fasting and fed conditions, respectively.
(a)

Parameter
FastingFed
TestReferenceTestReference
Mean ± SDMean ± SDMean ± SDMean ± SD

(ng /mL)22.69 ± 6.4921.93 ± 5.8521.62 ± 5.5621.10 ± 5.63
(h)1.51 ± 0.691.62 ± 0.852.11 ± 0.852.01 ± 0.65
(h)1.91 ± 0.251.90 ± 0.262.01 ± 0.242.03 ± 0.24
(h·ng/mL)88.72 ± 22.0086.26 ± 20.5092.69 ± 21.0093.36 ± 23.09
(h·ng/mL)89.56 ± 22.0987.13 ± 20.6393.66 ± 21.0794.27 ± 23.16
(1/h)0.369 ± 0.0450.372 ± 0.0500.351 ± 0.0460.346 ± 0.039

: maximum plasma concentration; : time point of maximum plasma concentration.
: half-life of drug elimination during the terminal phase.
: area under the plasma concentration—time curve from zero hour to 24 h.
: area under the plasma concentration—time curve from zero hour to infinity.
: elimination rate constant; SD: standard deviation.
(b)

ParameterRatio (test/reference), %90% CI (lower–upper)PowerIntrasubject variation, % CV
FastFedFastFedFastFedFastFed

Ln (ng/mL)103.1102.995.1–111.796.3–110.00.99740.999821.4114.57
Ln (h·ng/mL)102.7100.198.8–106.796.6–103.71.0001.00010.157.72
Ln (h·ng/mL)102.6100.198.8–106.696.7–103.71.0001.00010.067.64

CI: confidence interval; CV: coefficient of variation.

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