Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-03-28 @ 8:26 PM
Study NCT ID:
NCT03973632
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions
Sponsor:
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
NOT_YET_RECRUITING
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:
To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.
Detailed Description:
By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.
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?: