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Physiology and Pharmacology awt-yekta مجله فیزیولوژی و فارماکولوژی
:: Volume 2, Number 1 (بهار و تابستان 1377 1998) ::
Back to browse issues page Physiol Pharmacol 1998, 2(1): 40-44
XML Bioequivalence of sodium valproate tablets manufactured in Iran compared to its foreign counterpart Print

Author(s): Mohammad Hossein Pourgholami , Habibollah Saadat, Abolhassan Ahmadiani, majid Golkar, Hossein Amini and Maryam Goudarzvand
Study Type: Original Research | Subject:
Article abstract:

 

  In this double blind crossover study we assessed the bioequivalence of 200 mg enteric coated sodium valproate tablets manufactured by Roozdarou with 200 mg enteric coated sodium valproate (Orlept) manufactured by Desitin, Germany. Twelve healthy male volunteers were administered a single dose of 600 mg sodium valproate manufactured by Roozdarou, followed by a similar dose of Orlept, 2 weeks later. During the first 48 hours following each administration, 11 blood samples were obtained from each volunteer. Plasma levels of valproate were measured with a sensitive and selective HPLC method. Pharmacokinetic parameters were calculated for each administration to determine the bioequivalence of the two products, including maximum plasma concentration (Cmax), time to attain maximum plasma concentration (Tmax), and area under the plasma concentration-time curve (AUC). Comparison of these figures demonstrated no significant difference; therefore 200 mg enteric coated sodium valproate tablets manufactured by Roozdarou are bioequivalent to 200 mg enteric coated Orlept tablets.

KeywordsSodium valproate; Pharmacokinetics; Bioequivalence; HPLC,
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Pourgholami Mohammad Hossein, Saadat Habibollah, Ahmadiani Abolhassan, Golkar majid, Amini Hossein, Goudarzvand Maryam, Bioequivalence of sodium valproate tablets manufactured in Iran compared to its foreign counterpart Physiology and Pharmacology, 1998; 2 (1) :40-44
URL http://www.phypha.ir/ppj/browse.php?a_code=A-10-71-4&slc_lang=en&sid=1
 
Back to browse issues page Volume 2, Number 1 ( بهار و تابستان 1377 1998)
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