NCT02444507

A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product

A Randomized, Two-Way Crossover, Single-Dose Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product (Nexium Powder for Injection and Infusion 40 mg) in Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: isRed Pharma & Biotech Research Corporation · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.

Detailed description

This study is designed to assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan. Bioequivalence will be assumed if the 90% confidence interval of the AUC0-t, AUC0-inf and Cmax ratio are within the 80-125% interval for log-transformed values.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	Nexium powder for injection and infusion 40 mg	Reference Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
DRUG	Esomelone Powder for Solution for Injection / Infusion 40 mg	Test Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2015-05-14
• Last updated: 2015-05-14

Locations

1 site across 1 country: Taiwan