Table 3. Point estimate (test drug/reference drug) and 90% CIs of the pharmacokinetic parameters of fenofibric acid after single-dose administration of the 135 mg capsule (reference drug) and the 110 mg enteric-coated tablet (test drug) under fasting and fed conditions.
Variable | Point estimate | 90% CI | |
---|---|---|---|
Fasting study (n = 53) | |||
Cmax | 0.9195 | 0.8795–0.9614 | |
AUClast | 0.8630 | 0.8472–0.8791 | |
Fed study (n = 51) | |||
Cmax | 1.0926 | 1.0102–1.1818 | |
AUClast | 0.9998 | 0.9675–1.0332 |
CI, confidence interval; Cmax, maximum plasma concentration; AUClast, area under the concentration-time curve of the last measured concentration over the limit of quantitation.