Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917579
• Other study ID #: A2581166
• Status: Completed
• Phase: Phase 4
• Start date: July 2008
• Est. completion date: September 2008

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Atorvastatin
A single 10 mg dose of marketed 10 mg atorvastatin tablets
• Atorvastatin
A single 10 mg dose of new formulation of 10 mg atorvastatin

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)	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).	0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	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).	0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).	0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Secondary	Time to Reach Maximum Plasma Concentration (Tmax)	Tmax = time (hours) to maximum plasma concentration (Cmax).	0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Secondary	Plasma Elimination Half-life (t1/2)	t1/2 = terminal elimination half-life in hours.	0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose

External Links

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