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Bioequivalence Study Of Pediatric Appropriate Formulation

An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg (2x40 mg) Pediatric Appropriate Formulation To A 80 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00758004
Enrollment
76
Registered
2008-09-23
Start date
2008-10-31
Completion date
2009-03-31
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Cardiovascular Diseases

Brief summary

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

Detailed description

Determination of Bioequivalence

Interventions

DRUGAtorvastatin

A single dose of 80 mg atrovastatin tablet

DRUGAtorvastatin pediatric appropriate formulation

A single dose of pediatric appropriate atorvastatin 80 mg formulation

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.5 months

Secondary

MeasureTime frame
Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.5 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026