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Paper Information

Title: 

BIOEQUIVALENCE STUDY OF IRANIAN MADE CLOSANTEL VERSUS THE FOREIGN MADE ONE

Type: POSTER
Author(s): GHEZELOU Y.*,ARAB H.A.,RASOULI A.
 
 *PHARMACOLOGY DIVISION, VETERINARY FACULTY, UNIVERSITY OF TEHRAN
 
Name of Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Type of Seminar:  CONGRESS
Sponsor:  PHYSIOLOGY AND PHARMACOLOGY SOCIETY, MASHHAD UNIVERSITY OF MEDICAL SCIENCE
Date:  2007Volume 18
 
 
Abstract: 

Introduction: Closantel is a key anthelmintic drug against fluke, especially in sheep. It is produced in a veterinary pharmaceutical company in Iran, however, no bioequivalence study undergone on this drug.
Objective: It is aimed to examine the bioequivalence between Iranian made closantel (test) and foreign made one (reference).
Methods: 28 lambs, 4 to 5 months old were randomly divided into two groups. First group receives 10 mg/kg test closantel (Fascinil) and the second group received the same dose of reference closantel (Flukiver). Blood samples was taken on 0, 4, 8, 12, 16, 20, 24, 32, 48 and 72 hours after administering the drug and then analyzed by HPLC system. To compare the bioequivalence of two drugs, different pharmacokinetic parameters of Cmax, Tmax and AUC were calculated in each group and then analyzed with t-student and F tests.
Results: The mean of Cmax in test group was 71.70±13.02 and in reference group was 62.21±7.74 mg/ml. The mean of Tmax in test group was 23.28±4.12 and in reference group was 23.14±4.20 hours, and the mean of AUC (0-72) in test and reference groups were 2957.87±623.41 and 2912.99±648.17 mg/ml, respectively. There were not significant differences between the means of two groups in terms of the above values.
Conclusion: The results of this study showed that there was no significant difference between the plasma profiles of two tested closantel. It can be concluded that the closantel made by Iranian company is bioequivalent with closantel made by Belgian company.

 
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