Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers
NCT ID: NCT02587416
Last Updated: 2020-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2002-11-30
2002-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Gemcabene 300 mg
Gemcabene 300 mg
Gemcabene 300 mg
1x300 mg gemcabene tablets orally once daily (QD) for 11 days
Atorvastatin
2x40 mg Atorvastatin tablets orally once daily (QD)
Gemcabene 900 mg
Gemcabene 900 mg
Gemcabene 900 mg
3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
Atorvastatin
2x40 mg Atorvastatin tablets orally once daily (QD)
Atorvastatin 80 mg
Atorvastatin 80 mg
Atorvastatin
2x40 mg Atorvastatin tablets orally once daily (QD)
Interventions
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Gemcabene 300 mg
1x300 mg gemcabene tablets orally once daily (QD) for 11 days
Gemcabene 900 mg
3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
Atorvastatin
2x40 mg Atorvastatin tablets orally once daily (QD)
Eligibility Criteria
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Inclusion Criteria
* 18-65 years of age
* Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
* Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight \[kg\]/height\[meters\]²)
Exclusion Criteria
* History of significant adverse reaction to any lipid-lowering agent
18 Years
65 Years
ALL
Yes
Sponsors
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NeuroBo Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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A4141002
Identifier Type: -
Identifier Source: org_study_id
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