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Prilosec Bioequivalence Study in Healthy Volunteers

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioequivalence, AUC, Cmax, Pharmacokinetics

Intervention: Omeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
David Mathews, MD, Principal Investigator, Affiliation: Quintiles Phase I unit, Kansas
Helen Lunde, MD, Study Director, Affiliation: AstraZeneca

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules

Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules

Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules

Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules

Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules

Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules

Secondary outcome:

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole

Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male and female volunteers aged 18 to 50 years, inclusive, with suitable

veins for cannulation or repeated venepuncture.

- Female could be of nonchildbearing potential (postmenopausal or irreversible surgical

sterilization) and childbearing potential (negative pregnancy test at screening and use 2 effective methods of avoiding pregnancy).

- Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and a weight of at

least 50 kg and no more than 100 kg, inclusive. Exclusion Criteria:

- History of any clinically important disease or disorder which, in the opinion of the

Investigator, may either put the volunteer at risk because of participation in the study.

- History or presence of gastrointestinal, hepatic, or renal disease or any other

condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

- Any clinically important illness, medical/surgical procedure, or trauma within 4

weeks of the first administration of investigational medicinal product (IMP).

- Any clinically significant abnormalities in the physical examination, clinical

laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.

- Moderate to heavy smokers (more than 10 cigarettes per day or equivalent in

tobacco-containing products).

Locations and Contacts

Research Site, Overland Park, Kansas, United States
Additional Information

Starting date: August 2013
Last updated: November 21, 2013

Page last updated: August 23, 2015

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