Bioavailability Study for New Atorvastatin Formulation

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844376
• Other study ID #: A2581164
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: March 2008

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Estimation of Relative Bioavailability

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Atorvastatin suspension
A single dose of 80 mg Atorvastatin suspension
• Lipitor
A single dose of 80 mg Lipitor tablet

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	5 days
Secondary	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).	5 days
Secondary	Time to Reach Maximum Plasma Concentration (Tmax)	Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).	5 days
Secondary	Plasma Elimination Half-life (t1/2)	Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.	5 days

External Links

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