Bioequivalency Study of Zidovudine Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | June 2003 |
| End Date: | June 2003 |
A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fasting Conditions
The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg
tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fasting conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Inclusion Criteria:
- No clinically significant abnormal findings on physical exam, medical history, or
clinical laboratory findings during screening.
Exclusion Criteria:
- Allergic or adverse responses to zidovudine or any other comparable or similar
products.
- Participation in clinical trial within 30 days of study initiation.
- Positive blood screen for HIV, Hepatitis B and C.
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