Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions

NCT01146106 | Completed Phase 1

• 1 other identifier: AAI-US-139
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  1 month

Study Arms (2)

Pravastatin Sodium Tablets 80 mg

EXPERIMENTAL

Dr.Reddy's Laboratories Limited

Drug: Pravastatin Sodium

Pravachol 80 mg Tablets

ACTIVE COMPARATOR

Bristol Myers Squibb

Drug: Pravastatin Sodium

Interventions

Pravastatin Sodium DRUG

Pravastatin Sodium Tablets 80 mg

Also known as: Pravachol 80 mg tablets

Pravachol 80 mg Tablets; Pravastatin Sodium Tablets 80 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Pravastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Ralph Scallion EE, MD

  AAI, 6101 Quadrangle Drive, Chapel Hill, NC 27514

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: June 17, 2010
• Study Start: December 1, 2002
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: June 17, 2010

Record last verified: 2010-06