Status:
COMPLETED
Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
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 (Gla...
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. I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00779233
Start Date
September 1 2004
End Date
October 1 2004
Last Update
October 24 2008
Active Locations (1)
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1
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121