NCT04877834

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Karachi · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy
• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Dexlansoprazole	Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.
DRUG	Dexlansoprazole	Dexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm.

Timeline

• Start date: 2021-09-18
• Primary completion: 2022-10-25
• Completion: 2022-11-25
• First posted: 2021-05-07
• Last updated: 2023-11-29

Locations

1 site across 1 country: Pakistan