Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions

Single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets in Healthy Volunteers

This is a single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.

Study Overview

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

Detailed Description

Single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.

A total of 24 non-smoking subjects (18 men and 6 women) were included in this study, of which 23 finished the study according to the protocol.

The washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and females at least 18 years of age inclusive.
• Informed of the nature of the study and given written informed consent.
• Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and II).

Exclusion Criteria:

• Hypersensitivity to Pravastatin (pravachol®), or similar compounds.
• Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
• Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
• Donation of greater than 500 m1 of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
• Received an investigational drug within the 4 weeks prior to study dosing.
• Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins, or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
• Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
• If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pravastatin Sodium Tablets 80 mg; Dr.Reddy's Laboratories Limited	Drug: Pravastatin Sodium; Pravastatin Sodium Tablets 80 mg; Other Names: Pravachol 80 mg tablets
Active Comparator: Pravachol 80 mg Tablets; Bristol Myers Squibb	Drug: Pravastatin Sodium; Pravastatin Sodium Tablets 80 mg; Other Names: Pravachol 80 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC parameters	5 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Ralph Scallion EE, MD, AAI, 6101 Quadrangle Drive, Chapel Hill, NC 27514

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): November 1, 2002
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): January 13, 2012
• Last Update Submitted That Met QC Criteria: January 12, 2012
• Last Verified: June 1, 2010

More Information

Terms related to this study

• 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: AAI-US-138