Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-13
Brief Title:
Bioequivalence Study of EntacaponeLevodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
The Affiliated Hospital of Qingdao University
Study Overview
Official Title:
Single-Center Open Randomized Single-Dose Completely Repeated Crossover Bioequivalence Study to Evaluate the Effects of the TestReference Preparation EntacaponeLevodopa and Carbidopa Tablets II in the Postprandial State in Healthy Adult Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None