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Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin
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 Bioequivalence, pharmacokinetics, atorvastatin

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
  • Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Reference

Test

Arm Description

10 mg atorvastatin

New 10 mg atorvastatin tablet

Outcomes

Primary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).
Maximum Observed Plasma Concentration (Cmax)
Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).

Secondary Outcome Measures

Time to Reach Maximum Plasma Concentration (Tmax)
Tmax = time (hours) to maximum plasma concentration (Cmax).
Plasma Elimination Half-life (t1/2)
t1/2 = terminal elimination half-life in hours.

Full Information

First Posted
June 8, 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
NCT00917579
Brief Title
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
Official Title
An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet In Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 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
• To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Bioequivalence, pharmacokinetics, atorvastatin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Reference
Arm Type
Other
Arm Description
10 mg atorvastatin
Arm Title
Test
Arm Type
Experimental
Arm Description
New 10 mg atorvastatin tablet
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
A single 10 mg dose of marketed 10 mg atorvastatin tablets
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
A single 10 mg dose of new formulation of 10 mg atorvastatin
Primary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
Description
AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).
Time Frame
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description
AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).
Time Frame
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).
Time Frame
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Secondary Outcome Measure Information:
Title
Time to Reach Maximum Plasma Concentration (Tmax)
Description
Tmax = time (hours) to maximum plasma concentration (Cmax).
Time Frame
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Title
Plasma Elimination Half-life (t1/2)
Description
t1/2 = terminal elimination half-life in hours.
Time Frame
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose

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 between the ages of 18 and 55 years Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening. Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.
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
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581166&StudyName=Bioequivalence%20Study%20Comparing%20A%20New%2010%20Mg%20Atorvastatin%20Tablet%20To%20A%2010%20Mg%20Atorvastatin%20Commercial%20Tablet
Description
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Learn more about this trial

Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet

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