Huahai Pharmaceutical's Nonalanyl Ketone Tablets initiate a bioequivalence study for the indication of adult patients with chronic kidney disease related to type 2 diabetes (with albuminuria).

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that the bioequivalence study of Zhejiang Huahai Pharmaceutical Co., Ltd.'s Nelaridone Tablets (20 mg) in a single-dose postprandial state in healthy participants has been initiated. The clinical trial registration number is CTR20261265, and the first disclosure date is April 2, 2026.

The drug formulation is a tablet, with a dosage of oral administration, one tablet per dose, single administration per cycle. The main purpose of this trial is to evaluate the bioequivalence of the test formulation and the reference formulation, Kerendia (Nelaridone Tablets), in healthy male and female participants under postprandial conditions; the secondary purpose is to observe the safety of the two formulations in healthy participants.

Nelaridone Tablets are a chemical drug indicated for adults with chronic kidney disease related to type 2 diabetes (with albuminuria). The disease is caused by type 2 diabetes, which can lead to decreased kidney function, diagnosed through indicators such as eGFR and urine albumin; controlling blood sugar and protecting the kidneys are key.

The primary endpoints of this study include Cmax, AUC0-t, and AUC0-∞; secondary endpoints include Tmax, t1/2, kel (λz), AUC_%Extrap, as well as laboratory tests, electrocardiograms, physical examinations, vital signs, concomitant medications, adverse events, and serious adverse events.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 42 participants.

Disclaimer: The market carries risks; please invest cautiously. This article is automatically published by an AI large model based on third-party databases and does not represent Sina Finance’s views. All information in this article is for reference only and does not constitute personal investment advice. Please refer to the actual announcement for any discrepancies. If you have questions, contact biz@staff.sina.com.cn.

Massive information, precise interpretation, all on Sina Finance APP

Editor: Xiao Lang Express