Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877834
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2021-04-29
Brief Title:
Bioequivalence Study of DelanzoᵀᴹDR 60mg Dexlansoprazole Capsule With Dexilant 60mg Dexlansoprazole Capsule in Healthy Pakistani Subjects
Sponsor:
University of Karachi
Organization:
University of Karachi
Study Overview
Official Title:
A Single Center Open Label Randomized Single-dose Two-period Two-way Cross-over Study to Compare the Rate and Extent of Absorption of DelanzoᵀᴹDR 60mg Dexlansoprazole Capsule With Dexilant 60mg Dexlansoprazole Capsule in Healthy Pakistani Subjects
Status:
COMPLETED
Status Verified Date:
2023-11
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:
BABE
Brief Summary:
Single oral dose of study drug in two periods separated by a washout period of seven 07 days Blood samples will be taken up to 240 hours post-dose
Detailed Description:
Test Product DelanzoTMDR 60 mg Capsule manufactured by SAMI Pharmaceuticals Pvt Ltdor Reference Product Dexilant 60 mg Capsule manufactured by Takeda Pharmaceutical Company Limited will be administered to healthy male Pakistani volunteers with 240 mL ambient temperature water and blood samples will be taken up to 24 hours post dose for the calculation of Cmax Tmax AUC
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?:
None