Bioequivalence Study Of Pediatric Appropriate Formulation

NCT ID: NCT00758004

Last Updated: 2021-02-18

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-03-31

Brief Summary

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To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Detailed Description

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Determination of Bioequivalence

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Reference

Commercial 80 mg atorvastatin tablet

Group Type OTHER

Atorvastatin

Intervention Type DRUG

A single dose of 80 mg atrovastatin tablet

Test

Pediatric appropriate atorvastatin 40mg formulation

Group Type OTHER

Atorvastatin pediatric appropriate formulation

Intervention Type DRUG

A single dose of pediatric appropriate atorvastatin 80 mg formulation

Interventions

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Atorvastatin

A single dose of 80 mg atrovastatin tablet

Intervention Type DRUG

Atorvastatin pediatric appropriate formulation

A single dose of pediatric appropriate atorvastatin 80 mg formulation

Intervention Type DRUG

Other Intervention Names

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Atorvastatin

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female volunteers
* Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria

* Any condition possibly affecting drug absorption
* A positive urine drug screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A2581175

Identifier Type: -

Identifier Source: org_study_id

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