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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioavailability Study for New Atorvastatin Formulation

NCT00844376

Hypercholesterolemia

COMPLETED PHASE4

Bioequivalence Study On Pediatric Appropriate Formulation

NCT00777517

Hypercholesterolemia

COMPLETED PHASE1

Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"

NCT04325009

Healthy

UNKNOWN PHASE1

A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)

NCT01236430

Hyperlipidemia

COMPLETED PHASE1

A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)

NCT01370590

Hypercholesterolemia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reference

10 mg atorvastatin

Group Type OTHER

Atorvastatin

Intervention Type DRUG

A single 10 mg dose of marketed 10 mg atorvastatin tablets

Test

New 10 mg atorvastatin tablet

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

A single 10 mg dose of new formulation of 10 mg atorvastatin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin

A single 10 mg dose of marketed 10 mg atorvastatin tablets

Intervention Type DRUG

Atorvastatin

A single 10 mg dose of new formulation of 10 mg atorvastatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes