Shandong Langnuo Pharmaceutical Co., Ltd.

The main purpose of the study is to study the pharmacokinetics of the test preparation sildenafil citrate dry suspension (specification: 10 mg/mL, produced by Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference preparation sildenafil citrate dry suspension (Revatio®) (specification: 10 mg/mL, produced by Fareva Amboise) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary purpose of the study: to evaluate the safety of the test preparation sildenafil citrate dry suspension (specification: 10 mg/mL) and the reference preparation sildenafil citrate dry suspension (Revatio®) (specification: 10 mg/mL) in healthy subjects.

Primary objective: To evaluate the bioavailability of the test and reference preparations in healthy subjects after a single oral administration of the test and reference preparations in fasting and postprandial states, using Etogliflozin Tablets produced by Shandong Langnuo Pharmaceutical Co., Ltd. as the test preparation (T) and Etogliflozin Tablets (trade name: Steglatro®/Jianoto®) produced by Pfizer Manufacturing Deutschland GmbH as the reference preparation (R). Secondary objective: To evaluate the safety of the test and reference preparations in healthy subjects.

Main study objectives: To study the pharmacokinetic characteristics of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), produced by Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference preparation bisoprolol amlodipine tablets (Kangxinan®, specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine), produced by Egis Pharmaceuticals PLC) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary study objectives: To study the safety of the test preparation bisoprolol amlodipine tablets (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) and the reference preparation Kangxinan® (specifications: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)) in healthy subjects.