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| Sponsor: | Takeda Global Research & Development Center, Inc. |
|---|---|
| Information provided by (Responsible Party): | 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, once daily (QD), on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel, and to assess the safety of multiple doses of clopidogrel in healthy participants.
| 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: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
| Enrollment: | 160 |
| Study Start Date: | December 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | June 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.
Other Name: Plavix
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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.
Other Names:
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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.
Other Names:
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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.
Other Name: Plavix
|
|
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.
Other Names:
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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 dexlansoprazole, lansoprazole, omeprazole or esomeprazole on the steady-state pharmacokinetics (PK) and pharmacodynamics (PD) of clopidogrel in healthy participants.
Participants were randomized equally into eight regimen sequence groups, 20 participants each. Participants randomized to Sequence Groups 1 and 2, 3 and 4, 5 and 6 and 7 and 8 were called proton pump inhibitor (PPI) Groups 1, 2, 3, and 4, respectively. Each sequence group consists of 2 regimens. Sequence Groups 1, 3, 5 and 7 dosed Regimen A (75 mg clopidogrel) for Days 1-9 of Period 1 and then crossed 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 [2x40 mg] omeprazole), or Regimen E (75 mg clopidogrel + 40 mg esomeprazole). Sequence Groups 2, 4, 6 and 8 began with either Regimen B, C, D or E for Period 1 and then crossed over to Regimen A for Period 2.
On Day 9 of each period, blood samples were collected at predose and for 24 hours postdose to measure plasma concentrations of the active metabolite of clopidogrel. Platelet function was assessed daily prior to the dose of clopidogrel on Days 7-9 and 24-hours post Day 9 dose in each period. There was 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 participants were 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| United States, Arizona | |
| Tempe, 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. |
| ClinicalTrials.gov Identifier: | NCT00942175 History of Changes |
| Other Study ID Numbers: | TAK-390MR_101, U1111-1112-6792 |
| Study First Received: | July 16, 2009 |
| Results First Received: | May 31, 2011 |
| Last Updated: | February 1, 2012 |
| 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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Omeprazole Lansoprazole Clopidogrel Ticlopidine Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents |
Platelet Aggregation Inhibitors Hematologic Agents Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |