Bioequivalence Study Of Pediatric Appropriate Formulation

Viatris

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: Atorvastatin; Drug: Atorvastatin pediatric appropriate formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758004

A2581175

Details and patient eligibility

About

To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Full description

Determination of Bioequivalence

Enrollment: 76 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female volunteers
• 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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76 participants in 2 patient groups

Reference

Other group

Description:

Commercial 80 mg atorvastatin tablet

Treatment:

Drug: Atorvastatin

Test

Other group

Description:

Pediatric appropriate atorvastatin 40mg formulation

Treatment:

Drug: Atorvastatin pediatric appropriate formulation