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New Norvir Tablet Bioequivalence
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"A Pivotal Biostudy Comparing Ritonavir 100 mg Film-Coated Tablet to a Ritonavir 100 mg Soft Gelatin Capsule in Healthy Adult Subjects"
Reported by Jules Levin
IAC, Aug 3-8, 2008, Mexico City
Klein CE, Chiu YL, Awni W, Ng J, Xiong J, Roth W,
Podsadecki T, Kim D, Bernstein B.
Abbott Laboratories, Abbott Park, Illinois
BACKGROUND
Norvir Tablet Program objectives
- Develop a heat-stable ritonavir (RTV) tablet formulation while maintaining a boosting effect similar to that of the current RTV
Soft Gel Capsule (SGC)
- Ensure adequate stability due to worldwide use of RTV as pharmacokinetic enhancer, including in the developing world
Bioavailability data from a comparison of 3 prototype RTV tablet formulations to the RTV SGC were presented at
14th CROI in 20071
-- RTV prototype tablet formulations A and B met bioequivalence criteria with respect to RTV Cmax, AUCt and AUC∞
Stability issues precluded further development of these prototypes
-- The formulation was significantly revised and tested in the pilot bioequivalence Study M10-263
1. Cai Y. et al, 14th CROI, Los Angeles, February 2007, #52LB
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