Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00834379
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : February 3, 2009
Information provided by:
Teva Pharmaceuticals USA

Brief Summary:
The objective of this study is to compare the relative bioavailability of pravastatin sodium 40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: pravastatin sodium Drug: Pravachol® Phase 1

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Relative Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions
Study Start Date : September 2000
Actual Primary Completion Date : September 2000
Actual Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: pravastatin sodium
40 mg Tablet
Active Comparator: 2 Drug: Pravachol®
40 mg tablet

Primary Outcome Measures :
  1. Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Non-institutionalized subjects consisting of university students and members of the community at large.
  • All subjects selected for this study will be males 18 to 45 (inclusive) years of age. Weight of the subjects shall not be more than 15% ± from the normal for height and body frame (Metropolitan Life, 1993, Height, Weight, Body Chart).
  • Each subject shall be given a general physical examination within 21 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.

At the end of the study the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.

Adequate blood and urine samples should be obtained within 21 days before the beginning of the first period and at the end of the trial for clinical laboratory measurements.

Clinical laboratory measurements will include the following:

Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential)

Clinical Chemistry: creatinine, BUN, glucose, SGOT, SGPT, bilirubin, and alkaline phosphatase

Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells

HIV Screen: (pre-study only)

Hepatitis-B, C Screen: (pre-study only)

Drugs of Abuse Screen: (pre-study and at each dosing period check-in)

Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.

Exclusion Criteria

  • Subjects with a history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Subjects who have been exposed to known hepatic enzyme inducing or inhibiting agents within (30) days prior to dosing will not be allowed to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00834379

Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Principal Investigator: Dan Yeung, MD Pharma Medica Identifier: NCT00834379     History of Changes
Other Study ID Numbers: B006511
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: January 2009

Keywords provided by Teva Pharmaceuticals USA:
Healthy Subjects

Additional relevant MeSH terms:
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors