FTO x COMT x DDC x DRDs

To study the pharmacokinetic characteristics of the test preparation Entacapone Bidopa Tablets (II) and the reference preparation Dalingfu® in healthy participants after a single oral administration in the fasting and postprandial state, calculate the main pharmacokinetic parameters, compare the differences in pharmacokinetic parameters AUC and Cmax between the preparations, and evaluate whether the test preparation and the reference preparation are bioequivalent. To study the safety of the test preparation Entacapone Bidopa Tablets (II) and the reference preparation Dalingfu® in healthy Chinese participants.

Main research purpose: According to the relevant provisions of bioequivalence test, Orion Corporation is selected as the licensee of Entacapone Bidopa Tablets (II) (trade name: Dalingfu, specifications: levodopa 100mg, carbidopa 25mg, entacapone 200mg) as the reference preparation, and the test preparation Entacapone Bidopa Tablets (II) (specifications: levodopa 100mg, carbidopa 25mg, entacapone 200mg) provided by Sichuan Kelun Pharmaceutical Co., Ltd. is conducted on the human bioequivalence test of fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation Entacapone Bidopa Tablets (II) (Specifications: levodopa 100 mg, carbidopa 25 mg, entacapone 200 mg) and the reference preparation Entacapone Bidopa Tablets (II) (trade name: Dalingfu, specifications: levodopa 100 mg, carbidopa 25 mg, entacapone 200 mg) to healthy volunteers.

The aim of the study was to investigate the pharmacokinetics of the test preparation, Entacapone Bidopa Tablets (II) and the reference preparation, Darlingfu, in healthy adult subjects after a single oral administration, and to evaluate the bioequivalence and safety of the two oral preparations.