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Bioavailability Study for New Atorvastatin Formulation

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin suspension
Lipitor
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypercholesterolemia focused on measuring Cardiovascular Diseases

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Test

Reference

Arm Description

Extemporaneous preparation suspension Atorvastatin prototype formulation

Commercial atorvastatin tablet (Lipitor®)

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)
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
Terminal Phase Rate Constant (Kel)
Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).
Time to Reach Maximum Plasma Concentration (Tmax)
Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).
Plasma Elimination Half-life (t1/2)
Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.

Full Information

First Posted
February 13, 2009
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00844376
Brief Title
Bioavailability Study for New Atorvastatin Formulation
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Estimation of Relative Bioavailability

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cardiovascular Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Other
Arm Description
Extemporaneous preparation suspension Atorvastatin prototype formulation
Arm Title
Reference
Arm Type
Other
Arm Description
Commercial atorvastatin tablet (Lipitor®)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin suspension
Intervention Description
A single dose of 80 mg Atorvastatin suspension
Intervention Type
Drug
Intervention Name(s)
Lipitor
Other Intervention Name(s)
Atorvastatin
Intervention Description
A single dose of 80 mg Lipitor tablet
Primary Outcome Measure Information:
Title
Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)
Description
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).
Time Frame
5 days
Title
Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)
Description
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).
Time Frame
5 days
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)
Description
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
Time Frame
5 days
Title
Terminal Phase Rate Constant (Kel)
Description
Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).
Time Frame
5 days
Title
Time to Reach Maximum Plasma Concentration (Tmax)
Description
Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).
Time Frame
5 days
Title
Plasma Elimination Half-life (t1/2)
Description
Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581164&StudyName=Bioavailability%20Study%20for%20New%20Atorvastatin%20Formulation
Description
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Bioavailability Study for New Atorvastatin Formulation

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