Studies on the Bioequialence of Two Preparations of Gemfibrozil / 中国药房
China Pharmacy
;
(12)2001.
Article
in Chinese
| WPRIM
| ID: wpr-523862
ABSTRACT
OBJECTIVE:
To evaluate the bioequivalence of two preparations of gemfibrozil.METHODS:
A single oral dose of gemfibrozil enteric capsule(test preparation)and capsule(reference preparation)was given to20volunteers in an open ran?domized crossover way to study the pharmacokinetics and relative bioavailability.The plasma gemfibrozil concentrations were determined by HPLC method.RESULTS:
The pharmacokinetic parameters of test and reference preparations were as followsT max ,(2.4?0.6)h and(2.3?0.7)h;C max ,(21.8?7.3)?g/ml and(23.7?5.9)?g/ml;T 1/2 ,(2.0?0.4)h and(2.0?0.5)h;AUC 0~12 ,(68.1?13.7)(?g?h)/ml and(68.9?17.4)(?g?h)/ml;AUC 0~∞ (69.7?13.9)(?g?h)/ml and(70.6?17.8)(?g?h)/ml respectively.The relative bioavailability of test preparation was(100.8?15.0)%.The result of statistical analysis on above parameters showed that there was no significant difference between two preparations.CONCLUSION:
The two prepa?rations were bioequivalent.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Controlled clinical trial
Language:
Chinese
Journal:
China Pharmacy
Year:
2001
Type:
Article
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