Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions

NCT00779233 | Completed DMC

• 1 other identifier: 10440303
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

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

Interventions

Zidovudine tablets 300 mg DRUG

1; 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

Location

Related Links

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MeSH Terms

Interventions

Zidovudine

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: September 1, 2004
• Primary Completion: September 1, 2004
• Study Completion: October 1, 2004
• Last Updated: October 24, 2008

Record last verified: 2008-10

Locations

US (1)