Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pravastatin Sodium

• Registration Number: NCT01146106
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

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

Detailed Description

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

A total of 43 non-smoking subjects (31 men and 12 women) were included in this study, of which 43 finished the study according to the protocol.The study was performed as a single-dose two-way (80 mg), crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2010-02-10
• Status Verified: 2010-06
• Study First Submitted QC: 2010-06-16
• Last Update Submitted: 2010-06-16
• Study First Posted: 2010-06-17
• Last Update Posted: 2010-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Healthy males and females at least 18 years of age.
• 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 ll).

Exclusion Criteria

• Hypersensitivity to Pravastatin (pravachol®), or similar compounds.
• Any history ofa 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 ml 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, IDD, 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pravachol 80 mg Tablets	Pravastatin Sodium	Bristol Myers Squibb
Pravastatin Sodium Tablets 80 mg	Pravastatin Sodium	Dr.Reddy's Laboratories Limited

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC parameters	1 month