Copyright
©The Author(s) 2020.
World J Clin Cases. Nov 26, 2020; 8(22): 5518-5528
Published online Nov 26, 2020. doi: 10.12998/wjcc.v8.i22.5518
Published online Nov 26, 2020. doi: 10.12998/wjcc.v8.i22.5518
Table 3 Bioequivalence analysis of esomeprazole (fasting arm)–primary endpoint pharmacokinetics parameters (bioequivalence analysis set)
Average bioequivalence | Reference-scaled average bioequivalence | Intra-subject variability (%) | |||||||||
Parameters | n | GLSmean T | GLSmean R | Ratio (%) (T vs R) | 90%CI (%) | S2wr | Swr | Point estimate (0.8, 1.25) | Criteria bound (≤ 0) | CVwt | CVwr |
Cmax (ng/mL) | 32 | 1591.275 | 1527.891 | 104.15 | (98.20, 110.46) | 0.0427 | 0.2067 | 1.0415 | -0.0193 | 15.04 | 20.89 |
AUC0-t (h*ng/mL) | 32 | 3786.532 | 3597.451 | 105.26 | (99.80, 111.01) | 0.0484 | 0.2199 | 1.0526 | -0.0228 | 18.39 | 22.26 |
AUC0-inf (h*ng/mL) | 32 | 3830.746 | 3635.508 | 105.37 | (99.97, 111.06) | 0.0473 | 0.2175 | 1.0537 | -0.0222 | 18.31 | 22.01 |
- Citation: Liu ZZ, Ren Q, Zhou YN, Yang HM. Bioequivalence of two esomeprazole magnesium enteric-coated formulations in healthy Chinese subjects. World J Clin Cases 2020; 8(22): 5518-5528
- URL: https://www.wjgnet.com/2307-8960/full/v8/i22/5518.htm
- DOI: https://dx.doi.org/10.12998/wjcc.v8.i22.5518