An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet In Healthy Subjects
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
Study Overview
Brief Summary
• To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and/or female subjects between the ages of 18 and 55 years
- •Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
- •Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.
Arms & Interventions
Reference
10 mg atorvastatin
Intervention: Atorvastatin (Drug)
Test
New 10 mg atorvastatin tablet
Intervention: Atorvastatin (Drug)
Outcomes
Primary Outcomes
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).
Secondary Outcomes
- Plasma Elimination Half-life (t1/2)(0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose)
- Time to Reach Maximum Plasma Concentration (Tmax)(0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose)