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Bioequivalency of Omeraz, a test-product of Arab Pharmaceutical Manufacturing Company (Jordan) and Losec, a reference product by Astra (Sweden), was evaluated by a randomised crossover study on 22 healthy male volunteers. Serum concentrations of omeprazole were measured by an HPLC assay. There were no statistically significant differences between the two products in terms of serum profile and pharmacokinetic parameters including AUC, Cmax, Tlag, Tmax, MRT, Ke and T1/2. The AUC ratios (Omeraz/Losec) for 24 hours and for infinity were respectively 1.02 with a 90% C.L. of 0.88-1.16 and 1.00 with a 90% C.L. of 0.88-1.14. The two products may be considered as bioequivalent in terms of the extent of absorption as indicated by the AUC ratios. However, the confidence limits of Cmax fall outside the FDA accepted range.
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
January 2008,
Arzneimittel-Forschung,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
January 2007,
Arzneimittel-Forschung,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
January 2009,
Arzneimittel-Forschung,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
November 2016,
International journal of clinical pharmacology and therapeutics,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
January 2004,
International journal of clinical pharmacology and therapeutics,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
January 2009,
Arzneimittel-Forschung,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
March 1999,
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
November 2006,
International journal of clinical pharmacology and therapeutics,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
January 2006,
Arzneimittel-Forschung,
G K Pillai, and
M S Salem, and
N M Najib, and
J Jilani, and
M M Hasan, and
E Ghanem, and
E Sallam, and
M S Shubair, and
S al-Delq
January 2007,
Arzneimittel-Forschung,
