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Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects

Healthy Clinical Trial

Official title:
Single-Center, Open, Randomized, Single-Dose, Completely Repeated Crossover Bioequivalence Study to Evaluate the Effects of the Test/Reference Preparation, Entacapone,Levodopa and Carbidopa Tablets (II) in the Postprandial State in Healthy Adult Subjects

Clinical Trial Summary

In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout period (dosing interval) between doses will be at least 2 days. Taking the washout period of 2 days as an example, all subjects will take the corresponding medication according to the randomization table on day 1 of the first cycle trial, day 3 of the second cycle trial, day 5 of the third cycle trial, and day 7 of the fourth cycle trial.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06180720
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact Yu Cao
Phone 18661809090
Email caoyu1767@126.com
Status Not yet recruiting
Phase Phase 1
Start date December 20, 2023
Completion date November 20, 2024
View Details
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