Bioavailability Study for New Atorvastatin Formulation

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.12 enrolled

Overview

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.

Estimation of Relative Bioavailability

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Atorvastatin suspensionDRUG

A single dose of 80 mg Atorvastatin suspension

LipitorDRUG

A single dose of 80 mg Lipitor tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 5 days

Secondary Outcomes

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

Time frame: 5 days

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 frame: 5 days

Time to Reach Maximum Plasma Concentration (Tmax)

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

Time frame: 5 days

Data from ClinicalTrials.gov

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