Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT06768632
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Organization:
Study Overview
Official Title:
Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State
Status:
COMPLETED
Status Verified Date:
2025-01
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 overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fasting conditions. According to the randomized crossover self-control method, healthy volunteer subjects were orally administered with Eltrombopag Olamine Tablets produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Reference Listed Drug (RLD) on an empty stomach to evaluate the human bioequivalence of single dose administration, providing reference for their clinical evaluation and medication.
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?: