Shihuida Pharmaceutical Group (Jilin) Co., Ltd.

Main study objectives To study the pharmacokinetics of the test preparation levamlodipine besylate tablets (specification: 5mg, provided by Shihuida Pharmaceutical Group (Jilin) Co., Ltd.) and the reference preparation amlodipine besylate tablets (Norvasc®; specification: 10mg; licensee: Pfizer Pharmaceuticals Co., Ltd.) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives To evaluate the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy Chinese subjects in the fasting and fed state.

Main study objectives To study the pharmacokinetics of the test preparation levamlodipine besylate tablets (specification: 2.5mg, provided by Shihuida Pharmaceutical Group (Jilin) Co., Ltd.) and the reference preparation amlodipine besylate tablets (Norvasc®; specification: 5mg; licensee: Pfizer Pharmaceuticals Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after fasting and fed oral administration. Secondary study objectives To evaluate the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy Chinese subjects after a single oral administration in the fasting and fed state.

To evaluate the efficacy and safety of levoamlodipine-bisoprolol tablets in patients with essential hypertension whose blood pressure is poorly controlled after monotherapy with levoamlodipine besylate tablets or bisoprolol fumarate tablets.