Table 1.

Results of bioequivalence assessment for dantrolene (free acid) following single intravenous infusion of 60 mg Dantrium® or 60 mg NPJ5008 in healthy volunteers (n = 16)

Parameter	Adjusteda geometric mean NPJ5008 (test) (n = 16)	Adjusteda geometric mean Dantrium® (reference) (n = 16)	Ratio (test : reference)	90% CI	Largest P value from two one-sided tests	CVw
AUC0 to last (ng h  ml−1)	11 900	13 200	90.24%	85.94 to 94.76%	<0.001	7.85%
AUC0 to ∞ (ng h  ml−1)	12 300	13 600	90.44%	85.97 to 95.14%	<0.001	8.16%

AUC_{0 to ∞}, area under the curve from time zero extrapolated to infinity; AUC_{0 to last}, area under the curve from time zero to last measurable concentration; CI, confidence interval; CVw, geometric coefficient of intra-individual variability.

^aThe model was adjusted for fixed effects of period, regimen and sequence, and individual within sequence as a random effect. Of note there was a significant period effect, P = 0.021 for AUC_{0 to last} and P = 0.044 for AUC_{0 to ∞}, but no significant sequence effect was seen, therefore, the balanced crossover design meant period had no material impact on the results.