Prilosec Bioequivalence Study in Healthy Volunteers

Study Overview
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Brief Summary
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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

Official Title
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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
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Bioequivalence, AUC, Cmax, Pharmacokinetics

Intervention / Treatment
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* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omeprazole 20mg aqueous<br>Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test) | Drug: Omeprazole<br>* Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)<br>* Other names: Prilosec;|
| Active Comparator: Omeprazole 20mg organic<br>Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A) | Drug: Omeprazole<br>* Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)<br>* Other names: Prilosec;|
| Active Comparator: Omeprazole 40mg aqueous<br>Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test) | Drug: Omeprazole<br>* Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)<br>* Other names: Prilosec;|
| Active Comparator: Omeprazole 40mg organic<br>Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C) | Drug: Omeprazole<br>* Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)<br>* Other names: Prilosec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules | AUC | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules | AUC | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules | AUC (0-t) | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules | Cmax | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules | AUC(0-t) | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules | Cmax | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole | Cmax | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole | Cmax | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole | t1/2 | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole | tmax | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole | AUC(0-t) | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole | AUC | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 20-mg omeprazole | λz | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole | tmax | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole | AUC(0-t) | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole | AUC | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole | λz | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 
| Pharmacokinetics of 2 enteric-coated formulations after a single dose of 40-mg omeprazole | t1/2 | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence