Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642987
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Study to Evaluate the Bioequivalence of Vonopzan Tablet 20mgVonoprazan Fumarate and Vocinti Tablet 20mg in Healthy Adult Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomized Fasting Single-dose 2x2 Crossover Study in Healthy Subjects to Evaluate the Bioequivalence of Vonopzan Tablets 20mgVonoprazan Fumarate of Hanlim and Vocinti Tablet 20mgVonoprazan Fumarate of Takeda
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is an open-label randomized fasting single-dose two-sequence two-period crossover study in healthy subjects to evaluate the bioequivalence of Vonopzan Tablets 20 mgVonoprazan Fumarate of Hanlim Pharml Co Ltd and Vocinti Tablet 20 mg Vonoprazan Fumarate of Takeda Pharmaceuticals Korea Co Ltd in Healthy Adult Subjects
Detailed Description:
This study is to compare and evaluate the safety and pharmacokinetic characteristics of Vonopzan Tablets 20 mgVonoprazan Fumarate of Hanlim Pharm Co Ltd as the test drug and Vocinti Tablet 20 mg Vonoprazan Fumarate of Takeda Pharmaceuticals Korea Co Ltd as the reference drug in healthy adults
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None