Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

A Single-Dose, Comparative, Bioavailability Study of Two Formulations of Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pravastatin sodium 80 mg tablets; Drug: Pravachol® 80 mg tablets

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): 60
• 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: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, non-smoking male and female subjects, 18 years of age or older.
• BMI greater than or equal to 19 and less than or equal to 30.

• Negative for:

  • HIV.
  • Hepatitis B surface antigen and Hepatitis C antibody.
  • Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
  • Urine cotinine test
  • Serum HCG consistent with pregnancy (females only)
• No significant diseases or clinically significant findings in a physical examination.
• No clinically significant abnormal laboratory values.
• No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
• Be informed of the nature of the study and given written consent prior to receiving any study procedure.

• Females who participate in this study are:

  • unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy or,
  • willing to remain abstinent [not engage in sexual intercourse] or,
  • willing to use an effective method of double-barrier birth control [partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD].
• Females who participate in this study are non-lactating.

Exclusion Criteria:

• Known history or presence of any clinically significant medical condition.
• Known or suspected carcinoma.

• Known history or presence of:

  • Hypersensitivity or idiosyncratic reaction to pravastatin sodium and/or any other drug substances with similar activity.
  • Alcoholism within the last 12 months.
  • Drug dependence and/or substance abuse.
  • Use of tobacco or nicotine-containing products within the last 6 months.
• On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
• Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
• Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
• Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
• Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
• Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
• Difficulty fasting or consuming the standard meals.
• Do not tolerate venipuncture.
• Unable to read or sign the ICF.

Study Plan

How is the study designed?

Design Details

• 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 sodium 80 mg tablets; 1 x 80 mg
Active Comparator: Pravachol®; Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period	Drug: Pravachol® 80 mg tablets; 1 x 80 mg

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: Xueyu (Eric) Chen, M.D.; Ph.D ; FRCP (C), Pharma Medica Research, Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 9, 2009
• Last Verified: September 1, 2009

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: 2005-971