Shandong Penglai Nuokang Pharmaceutical Co. Ltd.

To evaluate the tolerability of multiple doses and multiple administrations of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease on hemodialysis (ESRD-HD) and hyperphosphatemia; To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease on hemodialysis (ESRD-HD) and hyperphosphatemia; To evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease on hemodialysis (ESRD-HD) and hyperphosphatemia.

Primary objective: To evaluate the tolerability of a single dose of lanthanum polystyrene sulfonate powder in healthy subjects; To evaluate the pharmacokinetics of a single dose of lanthanum polystyrene sulfonate powder in healthy subjects; To study the metabolic and excretion pathways of lanthanum polystyrene sulfonate powder in humans; Secondary objective: To preliminarily evaluate the pharmacodynamics; To evaluate the effect of food on the pharmacokinetics and pharmacodynamics of lanthanum polystyrene sulfonate powder (determine whether to proceed based on the tolerability results).

The main purpose of the study is to evaluate the bioequivalence of the two preparations in the fasting and fed states by taking a single oral dose of the test preparation metformin hydrochloride tablets (Penglai Nuokang Pharmaceutical Co., Ltd., specification: 250 mg) and the reference preparation metformin hydrochloride tablets (trade name: Glycoran®, Japan Shinyaku Co., Ltd., specification: 250 mg) in healthy adult subjects in the fasting and fed states. The secondary purpose of the study is to observe the safety of the test preparation and the reference preparation in healthy adult subjects.