NCT05976737

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

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 Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this trial, 32 healthy subjects are planned to be enrolled in fasting and 36 healthy subjects are planned to be enrolled in postprandial, and the fasting and 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 5 days. Taking the washout period of 5 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 6 of the second cycle trial, day 11 of the third cycle trial, and day 16 of the fourth cycle trial.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test (T) Entacapone,Levodopa and Carbidopa Tablets (II)	Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Produced and supplied by Qilu Pharmaceutical Co.
DRUG	Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)	Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Supplied by Qilu Pharmaceutical Co.

Timeline

• Start date: 2023-08-17
• Primary completion: 2023-09-07
• Completion: 2024-07-12
• First posted: 2023-08-04
• Last updated: 2023-08-04