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Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

NCT05235217 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-11

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

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

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2021-06-18
Completion
2021-06-18

Countries

  • Egypt

Study Locations

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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 NCT05235217 on ClinicalTrials.gov