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Paper Information

Journal:   ARCHIVES OF IRANIAN MEDICINE   January 2003 , Volume 6 , Number 1; Page(s) 44 To 48.
 
Paper: 

BIOEQUIV ALENCE STUDIES OF TWO IRANIAN GENERIC FORMULATIONS OF CAPTOPRIL IN HEALTHY VOLUNTEERS

 
 
Author(s):  FOROUTAN S.M.*, ZARGHI A., SHAFAATI A., KHODAM A.
 
* 
 
Abstract: 
Background and Objective - Captopril is a widely used anti hypertensive drug and is ‎formulated by several pharmaceutical companies in Iran. This study was conducted to ‎compare the bioavailability of two captopril formulations with reference products of the same ‎strength in healthy volunteers‏.‏‎
‎ Methods - The relative bioavailability of captopril was determined in two single-‎blind, single dose, randomized, crossover, two-phase studies. The relative ‎bioavailability of the test product (first study: generic captopril 25 mg tablets; second ‎study: generic captopril 50 mg tablets) with respect to the reference product (first ‎study: Capoten^R 25 mg tablets; second study: Capoten^R 50 mg tablets, Bristol-‎Myers Squibb) was determined. Twelve healthy volunteers in two groups took part in ‎these studies and took either the test or reference tablets in the first phase and received ‎the other tablet in the second phase of each study‏.‏‎
‎ Results - In the first study, the mean values for the variable peak plasma concentration ‎‎(C__max.) were 459.8 ng/mL for the reference and 466.6 ng/mL for the test product. ‎The mean values for the variable area under the curve (AUC__0-t) were 1392.5 ‎ng.hr/mL and 1403.2 ng.hr/mL for the reference and test product, respectively. In the ‎second study, the mean values for the variable C__max were 535.5 ng/mL for the ‎reference and 517.2 ng/mL for the test product. The mean values for the variable ‎AUC__0-t were 1518.8 ng.hr/mL and 1444.5 ng.hr/mL for the reference and test ‎product, respectively. The 90% confidence intervals for the test/reference mean ratios ‎of C__max and AUC__0.t were between 0.90 and 1.19, which is within the ‎conventional bioequivalence range of 80-125%‎‏.‏‎
‎ Conclusion - The test products were bioequivalent to the reference (Capoten^R) in ‎terms of the rate and extent of absorption of captopril in both 25 mg and 50 mg ‎strengths‏.‏
 
Keyword(s): BIOEQUIVALENCE .CAPTOPRIL TABLET .HPLC .HUMAN SERUM
 
References: 
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