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Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition

NCT06233149 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-31

No results posted yet for this study

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, full replicate crossover design with four-period, two-treatment, and two-sequence under fed condition and at least 7 days washout period between the doses.

Conditions

  • Healthy Subjects

Interventions

DRUG

Esomeprazole magnesium dihydrate-Test product

Esomeprazole magnesium dihydrate 40 mg tablets Manufactured by: Cipla Limited, India

DRUG

Esomeprazole magnesium dihydrate-Reference product

Esomeprazole magnesium dihydrate 40 mg tablets Manufactured by: AstraZeneca AB, Kingdom of Sweden

Sponsors & Collaborators

  • Bio-innova Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2024-11-19
Completion
2024-12-03

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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 NCT06233149 on ClinicalTrials.gov