Accession |
PRJCA017324 |
Title |
Bioequivalence ofPregabalin sustainedrelease tablets |
Relevance |
Medical |
Data types |
Random survey
|
Organisms |
Homo sapiens
|
Description |
The primary objective of this study is:To evaluate the bioequivalence of a single dose of Pregabalin Extended-Release Tablets 330 mg (Test product) and Lyrica CR (Reference product) in healthy male and female subjects under fasting conditions/subjects under fed conditions..The secondary objective of this study is:To observe the safety of a single dose of Pregabalin Extended-Release Tablets 330 mg and Lyrica CR in healthy subjects under fasting conditions/subjects under fed conditions.. |
Sample scope |
Multiisolate |
Release date |
2023-05-29 |
Grants |
Agency |
program |
Grant ID |
Grant title |
HQ Pharma (Shanghai) Co., Ltd.
|
BE
|
NA
|
Bioequivalence ofPregabalin sustainedrelease tablets
|
|
Submitter |
LV dongqing
dongqing
LV (lvdq@enzemed.com)
|
Organization |
Taizhou Enze MedicaCenter Group |
Submission date |
2023-05-26 |