Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

NCT ID: NCT02587390

Last Updated: 2020-04-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2000-07-31

Brief Summary

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The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Gemcabene 900 mg

Gemcabene 900 mg

Group Type EXPERIMENTAL

Gemcabene 900 mg

Intervention Type DRUG

3x300 mg Gemcabene tablets orally once daily (QD) for 15 days

Simvastatin 80 mg

Intervention Type DRUG

2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

Simvastatin 80 mg

Simvastatin 80 mg

Group Type ACTIVE_COMPARATOR

Simvastatin 80 mg

Intervention Type DRUG

2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

Interventions

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Gemcabene 900 mg

3x300 mg Gemcabene tablets orally once daily (QD) for 15 days

Intervention Type DRUG

Simvastatin 80 mg

2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and Females
* \>18 years of age
* Body weight 45 kg or greater

Exclusion Criteria

* If female, of childbearing potential or lactation
* History of significant adverse reaction to any fibrate lipid-lowering agent or HMG-CoA reductase inhibitor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NeuroBo Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1027-008

Identifier Type: -

Identifier Source: org_study_id

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