Pravastatin Sodium 40 mg Tablets Food Challenge Study

A Relative Bioavailability Food Challenge Study of Pravastatin Sodium 40 mg Tablets

The objective of this study is to compare the relative bioavailability of pravastatin 40 mg tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting conditions. A second objective is to compare the difference in plasma levels after dosing the test formulation with and without food.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: pravastatin; Drug: Pravachol®

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M1R 5A3
      • Pharma Medica Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pravastatin fast; Test product under fasting conditions dosed in first period followed by either test or reference product dosed under fed conditions in second and third periods	Drug: pravastatin; 40 mg tablet
EXPERIMENTAL: Pravastatin; Test product under fed conditions dosed in first period followed by either test product dosed under fasting conditions or reference product dosed under fed conditions in second and third periods	Drug: pravastatin; 40 mg tablet
ACTIVE_COMPARATOR: Pravachol®; Reference product under fed conditions dosed in first period followed by test product dosed under either fed or fasted conditions in second and third periods	Drug: Pravachol®; 40 mg Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax - Maximum Observed Concentration	Blood samples collected over 24 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)	Blood samples collected over 24 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)	Blood samples collected over 24 hour period

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions	Blood samples collected over 24 hour period
AUC0-inf - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions	Blood samples collected over 24 hour period
AUC0-t - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions	Blood samples collected over 24 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Primary Completion (ACTUAL): September 1, 2000
• Study Completion (ACTUAL): September 1, 2000

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (ESTIMATE): February 3, 2009

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

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: B006512