Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829309
First received: January 26, 2009
Last updated: September 9, 2009
Last verified: September 2009

January 26, 2009
September 9, 2009
March 2005
March 2005   (final data collection date for primary outcome measure)
  • Cmax - Maximum Observed Concentration - Pravastatin in Plasma [ Time Frame: Blood samples collected over 16 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 16 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 16 hour period ] [ Designated as safety issue: No ]
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829309 on ClinicalTrials.gov Archive Site
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Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions
A Relative Bioavailability Study of 80 mg Pravastatin Sodium Tablets Under Non-Fasting Conditions

This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80 mg tablet)in healthy adult male subjects administered under non-fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Pravastatin
    80 mg Tablet
  • Drug: Pravastatin
    80 mg Tablets
    Other Name: Pravachol® 80 mg Tablets
  • Experimental: Pravastatin
    Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
    Intervention: Drug: Pravastatin
  • Active Comparator: Pravachol®
    Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
    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
16
March 2005
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Screening Demographics: All subjects selected for this study will be healthy men 18 years of age or older at the time of dosing.
  • The subject's body mass index (BMI) should be less than or equal to 30.
  • Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing.
  • Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
  • Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature.
  • The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
  • The screening clinical laboratory procedures will include:

    • HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
    • CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
    • HIV antibody, hepatitis GB surface antigen, hepatitis C antibody screens
    • URINALYSIS: by dipstick; full microscopic examination if dipstick positive
    • URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine

Exclusion Criteria

  • Subjects with a recent history of drug or alcohol addiction or abuse.
  • Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
  • Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody.
  • Subjects demonstrating a positive drug abuse screen when screened for this study.
  • Subjects with a history of allergic response(s) to pravastatin or related drugs.
  • Subjects with a history of clinically significant allergies including drug allergies.
  • Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Subjects who currently or report using tobacco products within 90 days of Period I dose administration.
  • Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
  • Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  • Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  • Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
  • Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
  • Subjects who report an intolerance of direct venipuncture.
  • Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829309
R05-0202
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: James D Carlson, Pharm D PRACS Institute, Ltd.
Teva Pharmaceuticals USA
September 2009

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