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.