Table 2.
Statistical analysis of PK parameters of MMF following a single oral dose of Bafiertam™ (MMF) 2 × 95 mg or Tecfidera® (DMF) 1 × 240 mg
| Parameter | Bafiertam™ (MMF 2 × 95 mg) (test) | Tecfidera® (DMF 1 × 240 mg) (reference) | Statistical analysis results Test vs reference |
||||
|---|---|---|---|---|---|---|---|
| GLSM | n | GLSM | n | GLSM ratio (%) | 90% confidence interval | Intra-subject CV% |
|
| AUC0–t (ng*h/mL) | 2955 | 49 | 3053 | 49 | 96.80 | 92.18–101.64 | 14.48 |
| AUC0–inf (ng*h/mL) | 3002 | 48 | 3116 | 48 | 96.35 | 91.81–101.12 | 14.16 |
| C max (ng/mL) | 1760 | 49 | 1680 | 49 | 104.84 | 95.54–115.05 | 27.93 |
ANOVA analysis of variance, AUC area under the concentration–time curve, AUC 0–inf AUC from time 0 extrapolated to infinity, AUC 0–t AUC from time 0 to the time of the last measured non-zero analyte concentration, C max maximum observed concentration, CV coefficient of variation, DMF dimethyl fumarate, GLSM geometric least-squares mean, LSMs least-square means, MMF monomethyl fumarate, PK pharmacokinetic
Statistical analysis for bioequivalence was based on PK parameter data from subjects who completed the study and contributed PK parameter values for a pairwise comparison (i.e., from both treatments)
GLSMs were calculated by exponentiating the LSMs derived from the ANOVA
GLSM ratio = 100% × (test/reference)
Intra-subject CV% was calculated as 100% × square root(exp[MSE]−1), where MSE = residual variance from the ANOVA