Valsartan/Levamlodipine

The relative bioavailability of a single oral dose of the test preparation valsartan levoamlodipine tablets (specification: 80 mg/2.5 mg) and the reference preparations valsartan tablets (DIOVAN®, specification: 80 mg) and amlodipine besylate tablets (Norvasc®, specification: 5 mg) in healthy Chinese subjects under fasting conditions was studied, the pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations taken orally under fasting conditions was evaluated, so as to provide a reference for the application and clinical use of the drug.

To verify the superiority of the combination preparation over the single preparation and to evaluate the efficacy and safety of valsartan levoamlodipine tablets (80mg/2.5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled after 4 weeks of monotherapy with valsartan capsules (80mg) or amlodipine besylate tablets (5mg).