ผู้วิจัย/Authors: Wandee Taesotikul

ชื่อเรื่อง/Title: Bioequivalence of Clozapine Tablets

แหล่งที่มา/Source: Journal of The Psychiatric Association of Thailand, Vol. 45 No.3 July-September 2000, P 221-227.

รายละเอียด / Details:

Objective To perform a bioequivalence study of clozapine tablets between Clozaril? tablet (Novartis), the innovator product, and Clopaze? tablet (Pharminar, Thailand). Method The study was performed in 12 healthy male volunteers for a single 100 mg dose of clozapine tablet. Randomized cross over design was used. Blood samples were collected before and after drug administration for 24 hours and determined for plasma clozapine concentration by HPLC method. Results The results of the bioequivalence study of 100 mg clozapine tablets showed a high variation in pharmacokinetic parameters of both Clozaril? and Clopaze? similar to those reported elsewhere. When statistics were tested as stated in USP23 guideline for bioequivalence study, 90% confidence interval of the log of ratio of Cmax, AUC24hr and AUCinf between Clopaze? and Clozaril? were within the range of 0.80 - 1.25. Conclusion It can be indicated that the 100 mg Clozaril? and Clopaze? tablets used in this study are bioequivalent to each other.

Keywords: bioequivalence, clozapine, drug, antipsychotric drug, tranquilizer

ปีที่เผยแพร่/Year: 2000

Address: Biopharmacy Research Unit, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200

Code: 0000154

ISSN/ISBN: 0125-6985

Country of publication: Thailand.

Language: English.

Category: Abstract Journal.

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