Bioavailability Study for New Atorvastatin Formulation

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Atorvastatin suspension; Drug: Lipitor

• Registration Number: NCT00844376
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Results First Submitted: 2009-03-05
• Results First Submitted QC: 2009-09-18
• Results First Posted: 2009-10-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test	Atorvastatin suspension	Extemporaneous preparation suspension Atorvastatin prototype formulation
Reference	Lipitor	Commercial atorvastatin tablet (Lipitor®)

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	5 days	Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).
Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)	5 days	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)	5 days	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).

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)	5 days	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)	5 days	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)	5 days	Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).
Plasma Elimination Half-life (t1/2)	5 days	Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States