Study on Bioequivalence of Acetylcysteine Granules in Chinese Healthy Volunteers
10.3870/yydb.2015.08.007
- VernacularTitle:乙酰半胱氨酸颗粒在健康人体的生物等效性研究
- Author:
Jie LI
;
Mengzhou LIU
;
Weiyong LI
;
Mengmeng JIA
;
Ying ZHOU
;
Huqun LI
- Publication Type:Journal Article
- Keywords:
Acetylcysteine granules;
Bioavailability,relative;
Bioequivalence;
Liquid chromatography-tandem mass spectrometry
- From:
Herald of Medicine
2015;(8):1014-1018
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish an analytical method for assessing acetylcysteine in human plasma and study the relative bioavailability and bioequivalence of acetylcysteine granules in Chinese healthy volunteers. Methods In the randomized crossover study, 24 healthy male volunteers received a single oral dose of 0. 6 g test acetylcysteine granules, reference acetylcysteine granules or no medication. The plasma concentration of acetylcysteine was determined by LC-MS/MS. Pharmacokinetic parameters were calculated and bioequivalence of two preparations were evaluated by DAS3. 0 software. Results The main pharmacokinetic parameters of the test and reference preparations were as follows:AUC0→t was (8 547. 64± 2 860.04) and (8 783.07±4 042. 10) μg·h·L-1, respectively; AUC0→∞ was (9 481. 64±3 444. 76) and (9 540. 51± 4 239. 30) μg·h·L-1, respectively;Cmax was (1 994. 39±726. 42) and (2 090. 27±885. 46) μg·L-1, respectively;tmax was (1.18±0. 60) and (1. 13±0. 53) h, respectively; t1/2 was (8. 60±3. 76) and (7. 75±5. 01) h, respectively. The relative bioavailability F0→t and F0→∞ was ( 107. 0 ± 43. 3 )% and ( 106. 5 ± 40. 1 )%, respectively. Conclusion The results of statistical analysis indicate that the test and reference formulations are bioequivalent.
