Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fed Conditions
NCT ID: NCT00779376
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
68 participants
INTERVENTIONAL
2005-02-28
2005-04-30
Brief Summary
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Detailed Description
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A total of sixty-eight (68) healthy adult subjects (29 males and 39 females) were enrolled in the study, of which sixty five (65) subjects (29 males and 36 females) 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 300mg tablets of Ranbaxy
Zidovudine 300mg tablets
2
Retrovir ®) 300 mg Zidovudine tablets of Glaxosmithkline
Zidovudine 300mg tablets
Interventions
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Zidovudine 300mg tablets
Eligibility Criteria
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Inclusion Criteria
2. Weighing at least 52 kg for males and 45 kg for females within 15 % of their ideal weights (table of 'Desirable weights of Adults', Metropolitan Life Insurance Company, 1983)
3. Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs
4. Females of child bearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or were using one of the following acceptable birth control methods:
Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum; IUD in place for at least 3 months; Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study Surgical sterilization of the partner (vasectomy for 6 months minimum) Hormonal contraception for at least 3 months prior to the first dose of the study Other birth control method deemed acceptable
5. Postmenopausal women with amenorrhea for at least 2 years
6. Given voluntary written informed consent to participate in this study.
Exclusion Criteria
2. In addition history or presence of alcoholism or drug abuse within the past year, or hypersensitivity or idiosyncratic reaction to Zidovudine or to any other nucleoside analogue
3. Female subjects who were pregnant or lactating
4. Subjects who tested positive at screening for HIV, HBsAg or HCV
5. Subjects who have used any drugs or substances known to be strong inhibitors of cyp enzymes (formerly known as cytochrome p 450 enzymes) within 10 days prior to the first dose
6. Subjects who have used any drugs or substances known to be strong inducers of cyp enzymes (formerly known as cytochrome P 450 enzymes) within 28 days prior to the first dose and throughout the study
7. Subjects who through completion of the study would have donated in excess of 500 mL of blood in 14 days, 1500 mL of blood in 180 days or 2500 mL of blood in 1 year
8. Subjects who have participated in another clinical trial within 28 days prior to the first dose.
18 Years
55 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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MDS Pharma Services
Montreal, Quebec, Canada
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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AA26101
Identifier Type: -
Identifier Source: org_study_id