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Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

Bioequivalence Clinical Trial

Official title:
A Randomized, Single-Dose, Partial Replicate, Three-period, Three-sequence, Open-Label, Bioequivalence Study Comparing Esomeprazole in Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions

Clinical Trial Summary

The current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions.

Clinical Trial Description

A randomized, single-dose, two-treatment, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Esomeprazole plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05235217
Study type Interventional
Source Future University in Egypt
Contact
Status Completed
Phase Phase 1
Start date June 3, 2021
Completion date June 18, 2021
View Details
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