臨床薬理学および生物薬剤学

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Quantification of Saxagliptin Hydrochloride in Human Plasma and Dosage Forms by HPLC-MS/MS Method and Its Application to a Bioequivalence Study

Hesham Salem, Kamal Badr

Saxagliptin is an orally active, highly potent, selective and competitive dipeptidyl peptidase (DPP)-4 inhibitor used in the treatment of type 2 diabetes mellitus at doses of 2.5 or 5 mg once daily. The purpose of this study was to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations containing 5 mg saxagliptin in 30 healthy Egyptian volunteers. The two formulations were: A: Saxaliza 5 mg film coated tablets, manufactured by Hochster pharmaceutical industries(Egypt) and B: Onglyza 5 mg tablets, manufactured by AstraZeneca pharmaceuticals (USA). All these necessitate the need for a biometric tool to prove the drug pharmaceutical equivalence or bioequivalence.