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 4 Bioequivalence analysis of esomeprazole (fed 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 | 284.060 | 298.718 | 95.09 | (80.92, 111.75) | 0.3238 | 0.5690 | 0.9509 | -0.1689 | 53.05 | 61.84 |
| AUC0-t (h*ng/mL) | 32 | 958.8895 | 1065.110 | 90.03 | (79.29, 102.22) | 0.2281 | 0.4776 | 0.9003 | -0.1015 | 39.91 | 50.62 |
| AUC0-inf (h*ng/mL) | 26 | 1074.615 | 1271.273 | 84.53 | (72.99, 97.90) | 0.2260 | 0.4754 | 0.8453 | -0.0593 | 42.76 | 50.36 |
- 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