Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610903
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Bioequivalence Test of Hemay005 Tablets
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study Protocol for a Single-center Randomized Open-label Two-formulation Single-dose Two-cycle Double-crossover Fasting Bioequivalence Trial of Hemay005 Tablets in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations
Detailed Description:
To evaluate the pharmacokinetics and bioequivalence of the test formulation T1 and the control formulation T2 in healthy subjects under fasting state The safety of the two preparations in vivo was observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None