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

Viatris

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Genetic: Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00917644

A2581167

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Reference

Other group

Description:

80 mg atorvastatin tablets

Test

Experimental group

Description:

New 80 mg atorvastatin tablets

Treatment:

Genetic: Atorvastatin

Genetic: Atorvastatin