NCT00758004

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

September 22, 2008

Last Update Submit

February 17, 2021

Conditions

Hypercholesterolemia

Keywords

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.

    5 months

Secondary Outcomes (1)

  • Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.

    5 months

Study Arms (2)

Reference

OTHER

Commercial 80 mg atorvastatin tablet

Drug: Atorvastatin

Test

OTHER

Pediatric appropriate atorvastatin 40mg formulation

Drug: Atorvastatin pediatric appropriate formulation

Interventions

AtorvastatinDRUG

A single dose of 80 mg atrovastatin tablet

Reference
Atorvastatin pediatric appropriate formulationDRUG

A single dose of pediatric appropriate atorvastatin 80 mg formulation

Also known as: Atorvastatin
Test

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Any condition possibly affecting drug absorption
  • A positive urine drug screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

HypercholesterolemiaCardiovascular Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

US(1)