Prilosec Bioequivalence Study in Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics

Treatments: Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01921920

D9584C00010

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

54 participants in 4 patient groups

Omeprazole 20mg aqueous

Active Comparator group

Description:

Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test)

Treatment:

Drug: Omeprazole

Omeprazole 20mg organic

Active Comparator group

Description:

Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A)

Treatment:

Drug: Omeprazole

Omeprazole 40mg aqueous

Active Comparator group

Description:

Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test)

Treatment:

Drug: Omeprazole

Omeprazole 40mg organic

Active Comparator group

Description:

Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C)

Treatment:

Drug: Omeprazole