Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions - Full Text View

Sponsored by:	Ranbaxy Laboratories Limited
Information provided by:	Ranbaxy Inc.
ClinicalTrials.gov Identifier:	NCT00779233

Purpose

The purpose of this study is to evaluate the relative bioavailability of the test formulation of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.

Condition	Intervention
Healthy	Drug: Zidovudine tablets 300 mg

Drug Information available for: Zidovudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Official Title:	A Study to Compare the Relative Bioavailability of Ranbaxy and GlaxoSmithKline Formulation of Zidovudine Tablets 300 mg in Healthy Adult Volunteers Under Fasting Conditions.

Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:

Bioequivalence [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	September 2004
Study Completion Date:	October 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Zidovudine tablets 300 mg of Ranbaxy	Drug: Zidovudine tablets 300 mg
2: Active Comparator RETROVIR ® 300 mg tablets (GlaxoSmithKline)	Drug: Zidovudine tablets 300 mg

Detailed Description:

A randomized, single dose, two way crossover study was conducted with up to 32 healthy, male and female adult subjects to compare two Zidovudine 300 mg tablet formulations under fasting conditions.

In each period one x 300 mg tablet was administered to fasting subjects. Subjects received the test product in one study period and the reference product in the other period. The order of the treatment administration was as per the dosing randomization schedule. Each dose was separated by at least a 7 day interval.

A total of thirty two (32) subjects (23 males and 9 females) were enrolled for the study, of which only twenty eight (28) subjects completed the clinical portion of the study.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males and females, 18 to 65 years of age, inclusive with a body mass index (BMI) in the range 18-30 kg/m2 inclusive, measured according to Novum Standard operating Procedures
Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
Signed and dated informed consent form, which meets all criteria of current FDA regulations

Exclusion Criteria:

If female, pregnant, lactating or likely to become pregnant during the study
History of allergy or sensitivity to Zidovudine, or other antiviral or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction
Presence of gastrointestinal disease or history of malabsorption within the last year
History of psychiatric disorders occurring within the last two years that required hospitalization or medication
Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives)
Use of pharmacologic agents known to significantly induce or inhibit drug metabolizing enzymes within 30 days prior to dosing
Receipt of any drug as part of research study within 30 days prior to dosing.
Drug or alcohol addiction requiring treatment in the past 12 months
Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing
Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
Positive test results for drugs of abuse at screening
Positive serum pregnancy test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779233

Locations

United States, Nevada
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121

Sponsors and Collaborators

Ranbaxy Laboratories Limited

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Ranbaxy Research Labs ( Dr. Tausif Monif )
Study ID Numbers:	10440303
Study First Received:	October 23, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779233
Health Authority:	United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:

Bioequivalence

Study placed in the following topic categories:

Zidovudine
Healthy

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Antiviral Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009