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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole 20mg aqueous | Active Comparator | Treatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test) |
|
| Omeprazole 20mg organic | Active Comparator | Treatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A) |
|
| Omeprazole 40mg aqueous | Active Comparator | Treatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test) |
|
| Omeprazole 40mg organic | Active Comparator | Treatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference) |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mathews, MD | Quintiles Phase I unit, Kansas | Principal Investigator |
| Helen Lunde, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
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. |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |