Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
NCT ID: NCT01979185
Last Updated: 2021-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2013-11-18
2013-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Simvastatin
Administered as a single oral 20 mg dose on Day 1.
Simvastatin
Simvastatin + SSP-004184SS
Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
Simvastatin
SSP-004184SS
Interventions
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Simvastatin
SSP-004184SS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum ferritin, hemoglobin and erythrocyte indices within normal range
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States
Countries
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Other Identifiers
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SPD602-114
Identifier Type: -
Identifier Source: org_study_id
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