MedTrace Logo

Prilosec Bioequivalence Study in Healthy Volunteers

NCT01921920 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-11-25

No results posted yet for this study

Summary

This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck

Conditions

  • Bioequivalence, AUC, Cmax, Pharmacokinetics

Interventions

DRUG

Omeprazole

Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)

Sponsors & Collaborators

Principal Investigators

  • David Mathews, MD · Quintiles Phase I unit, Kansas

  • Helen Lunde, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01921920 on ClinicalTrials.gov