Phase 4
Completed N=12
Bioavailability Study for New Atorvastatin Formulation
Source: ClinicalTrials.gov NCT00844376 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2009
Primary outcomePrimary: Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48) — 135.05; 140.79 ng.h/mL
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.
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 | — |
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
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. Informational only — not medical advice.