Bioavailability Study for New Atorvastatin Formulation

NCT00844376 | Completed Phase 4 Results

• 1 other identifier: A2581164
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercholesterolemia

Keywords

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

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

  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).

  5 days

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

  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).

  5 days

• Maximum Observed Plasma Concentration (Cmax)

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

  5 days

Secondary Outcomes (4)

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

  5 days

• Terminal Phase Rate Constant (Kel)

  5 days

• Time to Reach Maximum Plasma Concentration (Tmax)

  5 days

• Plasma Elimination Half-life (t1/2)

  5 days

Study Arms (2)

Test

OTHER

Extemporaneous preparation suspension Atorvastatin prototype formulation

Drug: Atorvastatin suspension

Reference

OTHER

Commercial atorvastatin tablet (Lipitor®)

Drug: Lipitor

Interventions

Atorvastatin suspension DRUG

A single dose of 80 mg Atorvastatin suspension

Test

Lipitor DRUG

A single dose of 80 mg Lipitor tablet

Also known as: Atorvastatin

Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects
• Body 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

Sponsors & Collaborators

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

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: February 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 10, 2021
• Results First Posted: October 21, 2009

Record last verified: 2021-02

Locations

US (1)