NCT05235217

Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Future University in Egypt · Academic / Other
• Sex: Male
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Test product (T) 40 mg Hard Gelatin Capsules	Hard Gelatin Capsules products containing 40 mg Esomeprazole
DRUG	Reference product (R) 40 mg Hard Gelatin Capsules	Reference product (R) 40 mg Hard Gelatin Capsules

Timeline

• Start date: 2021-06-03
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2022-02-11
• Last updated: 2022-02-11

Locations

1 site across 1 country: Egypt