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Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. — BABE  

Healthy Clinical Trial

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.

Clinical Trial Summary

Single oral dose of study drug in two period(s) separated by a washout period of seven (07) days. Blood samples will be taken up to 24.0 hours post-dose.

Clinical Trial Description

Test Product DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd.or 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04877834
Study type Interventional
Source University of Karachi
Contact
Status Completed
Phase Phase 1
Start date September 18, 2021
Completion date November 25, 2022
View Details
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