Pharmacokinetic study of single oral administration of bismuth potassium citrate granules and bismuth potassium citrate tablets in Chinese healthy subjects

A clinical study on bismuth potassium citrate was conductedQualified subjects were randomly numbered in ascending order of screening number before taking the drug in the first cycle. The assignment of each subject (TR or RT) in the trial was determined by the randomization table. The fasting group plans to enroll 24 cases. The test was administered once per cycle, and the subjects were randomly divided into two groups with equal numbers in each group, and the washout period was 7 days. This project establishes and verifies an analytical method for the determination of bismuth concentration in human plasma by inductively coupled plasma mass spectrometry (ICP-MS). Results: The pharmacokinetic parameters (Cmax, AUC0-t and AUC0-∞) of the test preparation and reference preparation were analyzed by linear mixed effects model after natural logarithm transformation. The results showed that the test preparation was better than the reference preparation. The 90% confidence intervals of Cmax, AUC0-t and AUC0- ∞ after natural log transformation were 5.44%-12.82%, 10.86%-22.44% and 13.79%-27.42%, respectively. There, the lower limit of the 90% confidence interval of the geometric mean ratio (test preparation/reference preparation) is not greater than 100%.