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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pravastatin; Drug: Pravastatin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • PRACS Institute, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pravastatin; Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period	Drug: Pravastatin; 80 mg Tablet; Drug: Pravastatin; 80 mg Tablets; Other Names: Pravachol® 80 mg Tablets
Active Comparator: Pravachol®; Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period	Drug: Pravastatin; 80 mg Tablet; Drug: Pravastatin; 80 mg Tablets; Other Names: Pravachol® 80 mg Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Concentration - Pravastatin in Plasma	Bioequivalence based on Cmax	Blood samples collected over 16 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	Bioequivalence based on AUC0-inf	Blood samples collected over 16 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	Bioequivalence based on AUC0-t	Blood samples collected over 16 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: James D Carlson, Pharm D, PRACS Institute, Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): March 1, 2005
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (Estimated): January 27, 2009

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin
• Other Study ID Numbers: R05-0202