ABSTRACT
Abacavir Sulfate; Lamivudine; Zidovudine Tablets/Oral. Recommended studies: 2 studies. 1. Type of study: Fasting Design: single-dose, two-way crossover in vivo; Strength: 300 mg/150 mg/300 mg; Subjects: Normal, healthy males and females, general population. Additional comments: 2. Type of study: Fed Design: single-dose, two-way crossover in vivo; Strength: 300 mg/150 mg/300 mg; Subjects: Normal, healthy males and females, general population. Additional comments: Analytes to measure (in appropriate biological fluid): Abacavir, Lamivudine, and Zidovudine in plasma. Bioequivalence based on (90% CI): Abacavir, Lamivudine, and Zidovudine. Waiver request of in vivo testing: Not applicable.
