Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-31 @ 8:55 AM
Study NCT ID:
NCT05072535
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-dose, Randomized, Open-label, Two-period Crossover, Phase I Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-11
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 study will be divided into 2 parts. The first part is a relative bioavailability study of HA121-28 tablet A and HA121-28 tablet B, and the second part is a food effect study of HA121-28 tablet B. Both Parts are single-dose, randomized, open-label, two-period crossover study to evaluate relative bioavailability HA121-28 tablet B in healthy subjects and the effect of food on pharmacokinetic profile of HA121-28 tablet B, respectively.
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?: