Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions
NCT ID: NCT00779233
Last Updated: 2008-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2004-09-30
2004-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
Zidovudine tablets 300 mg of Ranbaxy
Zidovudine tablets 300 mg
2
RETROVIR ® 300 mg tablets (GlaxoSmithKline)
Zidovudine tablets 300 mg
Interventions
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Zidovudine tablets 300 mg
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
4. Signed and dated informed consent form, which meets all criteria of current FDA regulations
Exclusion Criteria
2. 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
3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction
4. Presence of gastrointestinal disease or history of malabsorption within the last year
5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication
6. Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives)
7. Use of pharmacologic agents known to significantly induce or inhibit drug metabolizing enzymes within 30 days prior to dosing
8. Receipt of any drug as part of research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months
10. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing
11. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
12. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody
13. Positive test results for drugs of abuse at screening
14. Positive serum pregnancy test
18 Years
65 Years
ALL
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Labs
Locations
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Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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10440303
Identifier Type: -
Identifier Source: org_study_id