In:
Clinical Pharmacology in Drug Development, Wiley, Vol. 11, No. 8 ( 2022-08), p. 987-996
Abstract:
The main objective of the study was to evaluate the bioequivalence of two rosuvastatin calcium tablets in healthy Chinese subjects under fasted and fed conditions. The study was carried out using a randomized, open‐label, two‐formulation, two‐sequence, two‐period, single‐dose crossover design, with a washout period of 7 days. Both the fasted study and fed study enrolled 28 subjects. In each study period, the subjects were administrated a single oral dose of the test product or reference product of rosuvastatin 10 mg. Blood samples were collected from pre‐dose to 72 hours after administration with 16 time points in total. Bioequivalence evaluation was performed using ln‐transformed pharmacokinetic parameters of rosuvastatin, including C max , AUC 0–t , and AUC 0–∞ . In the present study, 95% confidence intervals (CIs) of test/reference geometric mean ratios (GMRs) of C max , AUC 0–t , and AUC 0–∞ under the fasted and fed conditions were all within the acceptance range of 80%–125%. Additionally, only one subject experienced one adverse event (AE). High‐fat meals reduced the C max , AUC 0–t , and AUC 0–∞ , but had no significant effects on the λz, t 1/2 , or T max of rosuvastatin. In the current study, the test product was bioequivalent to the reference product, and a single dose of rosuvastatin (10 mg) was well‐tolerated. Food decreased the systemic exposure of rosuvastatin without the effects on the T max or elimination rate.
Type of Medium:
Online Resource
ISSN:
2160-763X
,
2160-7648
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2649010-9
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