Safety
nausea, Gastrointestinal adverse, gastrointestinal adverse, treatment-emergent adverse, TEAEs, vomiting, blood and coagulation
ADVERSE EVENTS, ADVERSE EVENT, EVENT
Among the 40 subjects in the fed trial, a total of 9 subjects reported 14 adverse events, all of which were TEAEs, including elevated blood triglycerides, positive bacterial test (urine), positive urinary leukocyte esterase, urine sediment detection, abnormal urinalysis, elevated gamma-glutamyl transferase, elevated alanine aminotransferase, increased human chorionic gonadotropin, abnormal electrocardiogram QRS wave complex, and nausea. Of which 3 cases in 3 subjects were grade 2 in severity and the rest were grade 1 in severity. Adverse events of severity grade 2 are mainly elevated blood triglycerides. Vital signs and physical examination were all normal and no clinically significant. For the 12-lead ECG, 1 subject showed abnormalities with clinical significance; for laboratory tests, 4 subjects showed abnormalities with clinical significance after taking the drug for blood biochemistry tests, 3 subjects showed abnormalities with clinical significance after taking the drug for routine urine tests, 1 subject showed abnormalities with clinical significance after taking the drug for blood pregnancy tests, and no abnormalities with clinical significance after taking the drug for routine blood and coagulation tests. There were no abnormalities and clinically significant blood tests. Of the 27 cases of TEAEs in this trial, 14 were cured, 12 had an unknown outcome, 1 had a persistent outcome, and there were no serious adverse events (Additional file Subject with a positive pregnancy test (screening number S117, random number: C004), who had normal pregnancy test during the screening period and two-period enrollment examination, was suspected to be pregnant based on human chorionic gonadotropin (β-HCG) of 435.62 IU/L during the second-period exit examination on July 01, 2020, and was asked whether sexual intercourse has occurred, the subject explained that she once had sexual intercourse and took contraception before enrollment. The β-HCG doubled two days later and pregnancy was highly suspected. Pregnancy was confirmed by gynecological color Doppler ultrasonography, and the pregnancy event was reported and followed up. On March 12, 2021, the subject delivered a female infant at 39-week gestation, and the newborn was born naturally in good condition with an Apgar score of 10.The more frequently reported adverse events after subjects took the test product and the reference product, ranked by system organ classification (SOC), were mainly elevated blood triglycerides in various tests, positive bacterial tests and positive urinary leukocyte esterase. The main gastrointestinal adverse event was nausea (Additional file Among the 40 subjects in the fasting trial, a total of 9 subjects reported 13 adverse events, all of which were treatment-emergent adverse events (TEAEs), this includes elevated C-reactive protein, decreased mean cell volume, elevated neutrophil count, nausea, and, as in the postprandial group, also elevated blood triglycerides, abnormal urinalysis, and vomiting. Of which 3 cases in 3 subjects were grade 2 in severity and the rest were grade 1 in severity. Vital signs, physical examination, and 12-lead electrocardiogram were all normal and no clinically significant; in terms of laboratory tests, after medication, 6 subjects showed abnormal and clinically significant blood biochemical tests, 2 subjects showed abnormal and clinically significant routine blood tests, 2 subjects showed abnormal and clinically significant routine urine tests, and pregnancy tests and coagulation tests were normal and clinically significant. Of the 13 cases of TEAEs in this trial, 8 were cured, 5 had an unknown outcome, and there were no serious adverse events (Additional file The more frequently reported adverse events after subjects took the test product and the reference product, ranked by SOC, were mainly elevated blood triglycerides in various tests, abnormal urinalysis, and elevated alanine aminotransferase. Gastrointestinal adverse events included vomiting and nausea (Additional file 