Shandong Hualu Pharmaceutical Co. Ltd.

The purpose of this study was to investigate the pharmacokinetic characteristics of entacapone tablets (200 mg) developed and produced by Shandong Hualu Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Entacapone tablets (Kedan®, 200 mg) produced by Orion Corporation was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

To observe the pharmacokinetic characteristics of the test and reference preparations of tipipenam-pivodile granules in healthy Chinese subjects after a single oral administration in the fasting/postprandial state and to evaluate the bioequivalence of the two preparations.

To study the pharmacokinetic characteristics of single and multiple doses of Tibipenem Pivoxil Granules in healthy humans, explore the characteristics of drug absorption, distribution, metabolism and excretion in the human body, provide research data for the registration application of Tibipenem Pivoxil Granules, provide reference basis for other clinical trials of Tibipenem Pivoxil Granules, and provide experimental basis for determining the clinical dosing regimen of Tibipenem Pivoxil Granules.