Bioavailability Study for New Atorvastatin Formulation

Viatris

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Atorvastatin suspension; Drug: Lipitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00844376

A2581164

Details and patient eligibility

About

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.

Full description

Estimation of Relative Bioavailability

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Test

Other group

Description:

Extemporaneous preparation suspension Atorvastatin prototype formulation

Treatment:

Drug: Atorvastatin suspension

Reference

Other group

Description:

Commercial atorvastatin tablet (Lipitor®)

Treatment:

Drug: Lipitor