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| Sponsor: | Takeda Global Research & Development Center, Inc. |
|---|---|
| Information provided by: | Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00942175 |
Purpose
The purpose of this study is to assess the potential effect and safety of multiple oral doses of dexlansoprazole, lansoprazole, omeprazole or esomeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel and to asses the safety of multiple doses of clopidogrel in healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Clopidogrel Drug: Clopidogrel and Lansoprazole Drug: Clopidogrel and Dexlansoprazole Drug: Clopidogrel and Omeprazole Drug: Clopidogrel and Esomeprazole |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | A Phase 1, Randomized, Open-Label, 2-Period, Crossover Design Study to Assess the Effects of Multiple Oral Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Steady-State Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Subjects |
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Regimen A
Clopidogrel 75 mg QD
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Drug: Clopidogrel
Clopidogrel 75 mg, tablets, orally, once daily days 1-9.
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Regimen B
Clopidogrel 75 mg QD and Lansoprazole 30 mg QD
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Drug: Clopidogrel and Lansoprazole
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily days 1-9.
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Regimen C
Clopidogrel 75 mg QD and Dexlansoprazole 60 mg QD
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Drug: Clopidogrel and Dexlansoprazole
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily days 1-9.
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Regimen D
Clopidogrel 75 mg QD and Omeprazole 80 mg QD
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Drug: Clopidogrel and Omeprazole
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily days 1-9.
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Regimen E
Clopidogrel 75 mg QD and Esomeprazole 40 mg QD
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Drug: Clopidogrel and Esomeprazole
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily days 1-9.
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This is a Phase 1, randomized, open-label, single-center, multiple-dose, 2-period, crossover study to assess the effects of multiple oral doses of once daily (QD) dexlansoprazole, lansoprazole, omeprazole or esomeprazole on the steady-state pharmacokinetics (PK) and pharmacodynamics of clopidogrel in healthy subjects.
Subjects will be randomized equally into eight regimen sequence groups, 20 subjects each. Subjects who are randomized to Sequence Groups 1 and 2, 3 and 4, 5 and 6 and 7 and 8 are called PPI Groups 1, 2, 3, and 4, respectively. Each sequence group will consist of 2 regimens. Sequence Groups 1, 3, 5 and 7 will dose Regimen A (75 mg clopidogrel) for Days 1-9 of Period 1 and then will cross over to one of the following 4 regimens for Days 1-9 of Period 2: Regimen B (75 mg clopidogrel + 30 mg lansoprazole), Regimen C (75 mg clopidogrel + 60 mg dexlansoprazole), Regimen D (75 mg clopidogrel + 80 mg omeprazole), or Regimen E (75 mg clopidogrel + 40 mg esomeprazole). Sequence Groups 2, 4, 6 and 8 will begin with either Regimen B, C, D or E for Period 1 and will then cross over to Regimen A for Period 2.
On Day 9 of each period, blood samples will be collected at predose and for 24 hours postdose to measure plasma concentrations of the active metabolite of clopidogrel. Platelet function will be assessed daily prior to the dose of clopidogrel on Days 7-9 and 24-hours post Day 9 dose in each period. There will be a washout interval of 10 to 14 days between the last dose of study drug in Period 1 and the first dose of study drug in Period 2.
Study subjects will be confined to the study center for 10 consecutive nights in Period 1, followed by a 10- to 14-day washout interval and confined for an additional 10 consecutive nights in Period 2.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
| United States, Arizona | |
| Recruiting | |
| Phoenix, Arizona, United States | |
| Study Director: | Medical Director Clinical Science | Takeda Global Research & Development Center, Inc. |
More Information
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
| Study ID Numbers: | TAK-390MR_101, U1111-1112-6792 |
| Study First Received: | July 16, 2009 |
| Last Updated: | January 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00942175 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Pharmacology Stomach Ulcer Esophagitis, Peptic Zollinger-Ellison Syndrome |
Platelet function PPI clopidogrel Pharmacokinetics and Pharmacodynamics |
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Anti-Infective Agents Ticlopidine Molecular Mechanisms of Pharmacological Action Hematologic Agents Gastrointestinal Agents Omeprazole Fibrinolytic Agents Enzyme Inhibitors |
Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents Clopidogrel Therapeutic Uses Anti-Ulcer Agents Platelet Aggregation Inhibitors Lansoprazole |