Discussion
ADVERSE REACTIONS, ADVERSE EVENTS
This study was conducted to compare the bioequivalence of two products of calcium dobesilate capsules, which were assessed by conducting an open-label, randomized, single-dose, 2-period crossover bioequivalence study in healthy Chinese volunteers under fasting and fed conditions. The results of this study can provide support for the marketing of the generic domestic calcium dobesilate capsules (0.5 g/capsule) in China.In this study, 26 and 70 healthy subjects completed the study under fasting and fed conditions respectively. A total of 75 subjects were enrolled in the fed study, of which 5 subjects dropped out before the first phase of administration (1 subject due to needle sickness and 4 due to inability to complete the high-fat, high-calorie breakfast). It suggests more attention should be paid to sample size estimates in clinical trial design under the fed conditions as the unpalatability of a high-fat, high-calorie diet in postprandial trials often results in a higher dropout rate.During the fasting study, only 1 subject had 2 adverse reactions related to the reference preparation, with an AE incidence rate of 3.8%. The frequency of adverse events was similar between the two preparations. During the fed study, 5 adverse reactions occurred in 4 subjects related to the test preparation, with an AE rate of 5.7%, and 9 adverse reactions occurred in 9 subjects related to the reference preparation, with an AE rate of 12.9% (detailed in Comparing the PK parameters of this study with the results reported in the literatures available [The values of some PK parameters changed when taking administration after taking high-fat and high-calorie meals. The TIn this study, under either fasting or fed conditions, the GMR of test/reference and their 90% Cis for CThe within-subject CV (CV