Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-02 @ 11:49 AM
Study NCT ID:
NCT06610903
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2024-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Test of Hemay005 Tablets
Sponsor:
Ganzhou Hemay Pharmaceutical Co., Ltd
Organization:
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:
COMPLETED
Status Verified Date:
2024-09
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:
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:
False
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?: