Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00830258
First received: January 26, 2009
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Pravastatin sodium 80 mg tablets
Drug: Pravachol® 80 mg tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, Comparative, Bioavailability Study of Two Formulations of Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: April 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830258

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Xueyu (Eric) Chen, M.D.; Ph.D ; FRCP (C) Pharma Medica Research Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00830258     History of Changes
Other Study ID Numbers: 2005-971
Study First Received: January 26, 2009
Results First Received: July 2, 2009
Last Updated: September 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014