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Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834379
First received: January 30, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention Phase
Healthy
Drug: pravastatin sodium
Drug: Pravachol®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: September 2000
Study Completion Date: September 2000
Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pravastatin sodium
40 mg Tablet
Active Comparator: 2 Drug: Pravachol®
40 mg tablet

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834379

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Dan Yeung, MD Pharma Medica
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00834379     History of Changes
Other Study ID Numbers: B006511
Study First Received: January 30, 2009
Last Updated: January 30, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Pravastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014