Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Genetic: Atorvastatin

• Registration Number: NCT00917644
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Results First Submitted: 2009-09-11
• Results First Submitted QC: 2009-09-11
• Results First Posted: 2009-10-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	Atorvastatin	80 mg atorvastatin tablets
Test	Atorvastatin	New 80 mg atorvastatin tablets

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	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). PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)	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). Pharmacokinetic (PK) parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
Maximum Observed Plasma Concentration (Cmax)	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); collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.

Secondary Outcome Measures

Name	Time	Method
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	Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence; PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.
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	t1/2 = terminal elimination half-life in hours; ln 2/kel, where kel is the termination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Miami, Florida, United States