NCT02543606

Bioequivalence of Two Formulations of Esomeprazole

A Randomized, Two-way Crossover, Single-dose Pharmacokinetic Study to Evaluate the Bioequivalence of Esomelone for Injection/Infusion (Esomeprazole 40mg), Compared to Reference Drug (Nexium 40mg) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Yung Shin Pharm. Ind. Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence of Two Formulations of Esomeprazole 40mg

Detailed description

A randomized, two-way crossover, single-dose pharmacokinetic study to evaluate the bioequivalence of a test formulation of Esomelone powder for solution for injection/infusion 40mg (Esomeprazole 40mg), compared to an equivalent dose of a reference drug product (Nexium powder for injection and infusion 40mg) in healthy adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Esomelone	powder for injection/ infusion Esomeprazole 40mg
DRUG	Nexium	powder for injection/ infusion Esomeprazole 40mg

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-09-07
• Last updated: 2015-09-07

Locations

1 site across 1 country: Taiwan