Cav1.2 x ADRA1 x β1-adrenergic receptor x Potassium channel

The main purpose of the study: According to the relevant provisions of the bioequivalence test, the dronedarone hydrochloride tablets (trade name: Maidalong, specification: 400mg) of Sanofi Aventis U.S., LLC as the licensee were selected as the reference preparation, and the human bioequivalence test of the test preparation dronedarone hydrochloride tablets (specification: 400mg) produced by Shijiazhuang Siyao Co., Ltd. was conducted to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under the condition of postprandial administration. The secondary purpose of the study: To observe the safety of the test preparation dronedarone hydrochloride tablets (specification: 400mg) and the reference preparation dronedarone hydrochloride tablets (trade name: Maidalong, specification: 400mg) taken orally by healthy volunteers.

To study the pharmacokinetics of a single oral dose of the test preparation dronedarone hydrochloride tablets and the reference preparation dronedarone hydrochloride tablets (Meidalong®) in healthy adult male subjects in the fasting/postprandial state, and to evaluate the bioequivalence and safety of the two preparations in the fasting/postprandial state.

Primary objective: To evaluate the pharmacokinetic characteristics of the test formulation of dronedarone hydrochloride tablets (specification: 400 mg, manufacturer: Jiangxi Kerui Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Metaron®, specification: 400 mg, manufacturer: Sanofi Winthrop Industrie) after a single oral administration under fasting and postprandial conditions in healthy Chinese subjects, and to investigate whether the two formulations are bioequivalent under fasting and postprandial conditions. Secondary objective: To evaluate the safety of the test formulation of dronedarone hydrochloride tablets (specification: 400 mg) and the reference formulation (trade name: Metaron®, specification: 400 mg) in healthy subjects.