Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide Tablet Under Fasting and Postprandial Conditions in Healthy Chinese Subjects.

The objective of this research was to evaluate and compare the pharmacokinetic profiles and safety of lisinopril/hydrochlorothiazide (10 mg/12.5 mg) tablets in the test and reference formulations administered to participants in both fasting and postprandial states and to evaluate the bioequivalence of the 2 products in healthy Chinese volunteers. This study employed a single-center, randomized, open-label, single-dose dosing trial involving a cumulative 96 healthy adult participants (60 in the fasting group and 36 in the postprandial group). Each group comprised 2 sequence sets, and a 2-week washout period was implemented. There were no statistically significant differences in time to maximum concentration and terminal elimination half-life between the test and control groups under fasting and postprandial conditions (P > .05), and the 90% CIs for area under the plasma concentration-time curve and maximum plasma concentration were within the bioequivalence range of 80%-125%. Pharmacokinetic results indicate a large food effect for lisinopril, meaning that there is a loss of approximately 20%-25% of systemic exposure from fasting to postprandial administration for both preparations. The study demonstrated that a single oral dose of generic lisinopril/hydrochlorothiazide is bioequivalent to the reference product and well tolerated, with no significant adverse events observed, and that both products are similarly safe in a cohort of healthy Chinese male and female participants, following administration under fasting and postprandial conditions.

[Comparison of pharmacokinetics of tetrahydropalmatine monomer and extractive of corydalis and corydalis processed with vinegar].

OBJECTIVE: To investigate the pharmacokinetics of tetrahydropalmatine monomer and extractive of corydalis and corydalis processed with vinegar in rats. METHODS: The plasma concentrations of tetrahydropalmatine were determined by a reversed phase high performance liquid chromatographic. The plasma concentrations-time data were calculated with 3p97 program. RESULTS: The main pharmacokinetic parameters of tetrahydropalmatine monomer and extractive of corydalis and corydalis processesd with vinegar as follows: T(1/2) was (5.66 +/- 1.92), (4.24 +/- l1.54), (4.35 +/- 1.34) h, Tmax was (1.5 +/- 0.5), (1.0 +/- 0.55), (0.5 +/- 0.68) h, Cmax was (0.71 +/- 0.29), (0.37 +/- 0.11), (0.67 +/- 0.35) microg/ml,AUC(o-t), was (2.58 +/- 0.85), (1.96 +/- 0.69), (2.95 +/- 1.61) microg/ml. CONCLUSION: The T(1/2) of corydalis and corydalis processesd with vinegar is more shorter than tetrahydropalmatine monome, the effect of preventing pain is promoted in rats.