MedTrace Logo

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

NCT02444507 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-05-14

No results posted yet for this study

Summary

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

Conditions

  • Healthy Adult Subjects

Interventions

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.

Sponsors & Collaborators

  • Yung Shin Pharmaceutical Ind. Co., Ltd.

    collaborator UNKNOWN

  • isRed Pharma & Biotech Research Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444507 on ClinicalTrials.gov