Pharmacokinetics and bioequivalence of two ?-Lipoic acid preparations in Chinese healthy volunteers / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12)2004.
Article
in Chinese
| WPRIM
| ID: wpr-566166
ABSTRACT
AIM:
To develop a high performance liquid chromatography -mass spectrometry method for the determination of ?-Lipoic acid in plasma,to study the pharmacokinetics of ?-Lipoic acid and evaluate the bioequivalence of two preparations in healthy subjects.METHODS:
A single oral dose of 200 mg ?-Lipoic acid capsules and tablets was given to 22 healthy male volunteers according to an open randomized 2 way crossover design. Plasma concentrations of ?-Lipoic acid were determined by HPLC-MS method. The pharmacokinetic parameters and relative bioavailability were calculated to evaluate the bioequivalence of the two preparations.RESULTS:
The pharmacokinetic parameters of the two products were as followstmax were (16?4) and (20?20) min,?max were (1490?359) and (1537?290) ng/mL,AUC0-t were (59559?18456) and (58210?15080) ng?mL-1?min,AUC0-∞ were (60068?18556) and (58634?15126) ng?mL-1?min,respectively. The relative bioavailability of AUC0-t and AUC0-∞ were (102.97?18.28)% and (103.09?18.26)%.CONCLUSION:
The result demonstrated that two formations are bioequivalent by statistical analysis of variant,two one-side t-test and 90% confidential interval.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Controlled clinical trial
Language:
Chinese
Journal:
Chinese Journal of Clinical Pharmacology and Therapeutics
Year:
2004
Type:
Article
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