Bioequivalence of daclatasvir hydrochloride tablets in healthy Chinese subjects.

OBJECTIVE: The aim of the present study was to evaluate the bioequivalence and safety of two types of daclatasvir hydrochloride tablets administered to healthy Chinese subjects under fasting and postprandial conditions. MATERIALS AND METHODS: A total of 72 healthy Chinese subjects were randomly divided into two groups: the fasting group (n = 36) and the postprandial group (n = 36). A dose of 60 mg of both the test and reference preparations of the daclatasvir hydrochloride tablets was taken orally under fasting and postprandial conditions. RESULTS: The main plasma pharmacokinetic parameters of the test and reference preparations in the fasting group were as follows: T1/2 was 9.82 ± 1.00 and 9.67 ± 0.99 hours, respectively; tmax was 1.00 hour in both; Cmax was 1,528.25 ± 428.80 and 1,504.25 ± 414.50 ng/mL-1, respectively; AUC0-t was 14,553.04 ± 4,013.26 and 14,391.97 ± 4,078.18 h/ng/mL-1, respectively; the AUC0-∞ was 14,660.80 ± 4,018.37 and 14,494.85 ± 4,095.57 ng/mL-1, respectively. Meanwhile, the main plasma pharmacokinetic parameters of the test and reference preparations in the postprandial group were as follows: T1/2 was 10.18 ± 1.38 and 10.18 ± 1.69 hours, respectively; tmax was 2.00 and 1.75 hours, respectively; Cmax was 974.92 ± 248.50 and 981.44 ± 237.11 ng/mL-1, respectively; AUC0-t was 9,597.00 ± 3,094.28 and 9,982.83 ± 3,512.07 h/ng/mL-1, respectively; AUC0-∞ was 9,712.92 ± 3,130.43 and 10,113.97 ± 3,593.47 ng/mL-1, respectively. CONCLUSION: Both types of daclatasvir hydrochloride tablets demonstrated good safety levels in healthy Chinese subjects under both fasting and postprandial conditions. Moreover, the two preparations were bioequivalent.

[Safety and Tolerance of Healthy People to Injection of Astragalosides-a New Drug for Coronary Heart Disease].

OBJECTIVES: To assess the safety and tolerance of healthy volunteers to as tragalosides injection (AGI), and to determine a safe dose range for phase II clinical trial. METHODS: A total of 62 healthy volunteers participated in this study, with 26 being given a single AGI of 100 mL, 200 mL, 300 mL, 400 mL, 500 mL, or 600 mL and 36 subjects being given 500 mL, 400 mL, 200 mL or 300 mL of AGI once a day for 7 d. Discomfortsymptoms, vital signs and safety problems were recorded 3 d and 7 d after the administration of AGI. The results were analyzed. RESULTS: Of the 62 participants, 40 adverse events (AEs) were reported by 31 participants, which included 23 mild adverse reactions (ADRs) and 4 moderate ADRs. Nine AEs were reported by 9 participants with single AGI, including 7 ADRs. Fourteen AEs were reported by 10 participants with 500 mL and 400 mL multiple AGI, including 12 ADRs occurred in 9 participants.Seventeen AEs were reported by 12 participants with 300 mL and 300 mL multiple AGI, including 3 mild ADRs. The main ADRs included abnormal liver function [slightly elevated glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST),and serum total bilirubin (TBil)], low blood potassium, increased urine red blood cell count, rash, and phlebitis. CONCLUSIONS: The maximum tolerance is 600 mL for single-dose treatment, and 400 mL for multiple-dose (7 d). The dose guidance given in this study should be examined its effects and safety in patients with coronary heart disease in phase II clinical trial.