Prilosec Bioequivalence Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics
• Interventions: Drug: Omeprazole

• Registration Number: NCT01921920
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-14
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omeprazole 20mg aqueous	Omeprazole	Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test)
Omeprazole 20mg organic	Omeprazole	Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A)
Omeprazole 40mg aqueous	Omeprazole	Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test)
Omeprazole 40mg organic	Omeprazole	Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C)

Primary Outcome Measures

Name	Time	Method
Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules	predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.	Cmax
Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules	predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.	Cmax

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole	predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.	λz
Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole	predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.	t1/2

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States