Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Genpharm ULC
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00650221
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008

March 30, 2008
March 31, 2008
June 2003
July 2003   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00650221 on ClinicalTrials.gov Archive Site
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Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects
A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects

The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions.

Based on the results from this study, the two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Therapeutic Equivalency
  • Drug: Pravastatin
    Single-dose 80 mg immediate-release oral tablet
  • Drug: Pravastatin
    Single-dose 80 mg immediate-release tablet
    Other Name: Pravachol®
  • Experimental: 1
    Intervention: Drug: Pravastatin
  • Active Comparator: 2
    Intervention: Drug: Pravastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2003
July 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects meeting the following criteria may be included in the study:
  • Non-smoking male or female with a minimum age of 18 years.
  • Body Mass Index (BMI = weight/height2) greater than or equal to 19 kg/m2 and less than or equal to 26 kg/m2.
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
  • Normal findings in the physical examination, 12‑lead ECG and vital signs (blood pressure between 100‑140/60‑90 mmHg, heart rate between 50-99 beats/min and temperature between 35.8°C and 37.5°C).
  • Negative for drugs of abuse, nicotine , alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).
  • No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
  • Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.

Exclusion Criteria:

  • Subjects meeting any of the following criteria will be excluded:
  • Known history of hypersensitivity to pravastatin sodium (e.g. Pravachol®, Lipostat®) and/or related drugs such as simvastatin (Zocor®), atorvastatin (Lipitor™), cerivastatin (Baycol®) or fluvastatin (Lescol®).
  • Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
  • Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • Any clinically significant illness during the last four weeks prior to entry into this study.
  • Presence of any significant physical or organ abnormality.
  • Any subject with a history of drug abuse.
  • Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
  • Use of any prescription medication within 14 days preceding entry into this study.
  • Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
  • Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
  • Female subjects: presence of pregnancy or lactation.
  • Any subject who has had blood withdrawals within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
  • Participation in a clinical trial with an investigational drug within 30 days preceding this study.
  • Any subject who has donated blood within 56 days preceding this study.
  • Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
  • Significant or recent history of asthma (after 12 years of age).
  • Any subject with a recent (less than one year) history of alcohol abuse.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00650221
2721
Yes
Elliot Offman, Director, Biopharmaceutics, Genpharm ULC
Mylan Pharmaceuticals
Genpharm ULC
Principal Investigator: Paul Tam, MD Biovail Contract Research
Mylan Pharmaceuticals
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP