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Completed

NCT Number: NCT00844376

Bioavailability Study for New Atorvastatin Formulation

The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development.

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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

Estimation of Relative Bioavailability

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Atorvastatin suspension

Drug

A single dose of 80 mg Atorvastatin suspension

Lipitor

Drug

A single dose of 80 mg Lipitor tablet

Other names: Atorvastatin

Primary outcomes

  1. Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)

    Time frame: 5 days

    Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus [vs] reference); measured in nanograms times hour per milliliter (ng.hr/mL).

  2. Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)

    Time frame: 5 days

    Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 5 days

    Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).

Secondary outcomes

  1. Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)

    Time frame: 5 days

    Geometric mean of AUClast = area under the plasma concentration-time curve from time zero (0) to the last measurable concentration of atorvastatin (test vs reference); measured as ng.hr/mL

  2. Terminal Phase Rate Constant (Kel)

    Time frame: 5 days

    Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).

  3. Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: 5 days

    Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).

  4. Plasma Elimination Half-life (t1/2)

    Time frame: 5 days

    Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open Label, Single Dose, Randomized 2-Way Crossover Study To Estimate The Relative Bioavailability Of Atorvastatin Commercial Tablet, And An Extemporaneous Preparation (EP) Suspension Formulation, In Healthy Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 16, 2009
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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