Phase 4 N=12 Randomized Other

Bioavailability Study for New Atorvastatin Formulation

Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00844376 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2009

Primary outcome: Primary: Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48) — 135.05; 140.79 ng.h/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Atorvastatin suspension (Drug); Lipitor (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)	135.05; 140.79	—
PRIMARY Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)	135.88; 142.86	—
PRIMARY Maximum Observed Plasma Concentration (Cmax)	38.74; 33.24	—
SECONDARY Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)	130.21; 137.49	—
SECONDARY Terminal Phase Rate Constant (Kel)	0.12; 0.10	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax)	0.52; 0.50	—
SECONDARY Plasma Elimination Half-life (t1/2)	5.95; 7.21	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00844376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.