Tianjin Taipu Medicine Technology Development Co., Ltd.

Main research purpose: To evaluate the efficacy and safety of Picrorhizon Total Glucoside Capsules in the treatment of non-alcoholic steatohepatitis and explore the clinical dose. Exploratory research purpose: Analysis of ferritin, inflammatory factors and metabolomics in non-alcoholic steatohepatitis.

Healthy subjects were selected as subjects, starting from a safe initial dose, to observe the body's tolerance to Picrorhizon Total Glucosides Capsules, determine the maximum tolerated dose, collect adverse reactions, and provide a safe dosage range for the formulation of the Phase II clinical trial plan for this product.

This study investigated the pharmacokinetic characteristics of a single oral dose of entecavir tablets (0.5 mg/tablet) developed by Tianjin Taipu Pharmaceutical Technology Development Co., Ltd. and entecavir tablets (trade name: Baraclude®, 0.5 mg/tablet) produced by Bristol-Myers Squibb Company under fasting conditions, compared their relative bioavailability, and evaluated the bioequivalence between the two preparations, providing a basis for the registration application of entecavir tablets developed by Tianjin Taipu Pharmaceutical Technology Development Co., Ltd.