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Subjects received lamivudine (150 mg), stavudine (40 mg), and nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation.
For lamivudine, the Cmax was 20% lower with the generic compared to the brand formulation while for stavudine the Cmax was 30% higher with the generic compared to the brand formulation.
A sample size of 18 subjects was estimated using a formula by Zhang et al. [6] to provide 80% power to detect approximately a 20% difference on a log scale in AUC0 12h and Cmax between the brand formulation and the generic formulation.
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We already have concepts and brand formulations for five years' time," says Mr Mateschitz.
The generic formulation was not statistically bioequivalent to the brand formulations during steady state, although exposures were comparable.
We compared the steady-state pharmacokinetics of lamivudine, stavudine and nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®).
Thus, Monsanto Company© advise growers that sowing of a new crop may commence safely as little as 4 h post-spray treatment with Roundup WeatherMAX® and 24 72 h post-spray treatment with all other Roundup® brand formulations [26].
All drug samples were tested against approved U.S. brand formulations using Raman spectrometry.
All patients had measurable levels of each drug prior to administration of both the generic and brand formulations.
The mean concentration-time profiles over 12 hours for each drug after administration of the generic and brand formulations are shown in Figure 1.
The generic formulation (Triomune-40) was manufactured by Cipla (Mumbai, India) and the brand formulations by: Zerit, Bristol- Myers Squibb, Princeton, NJ, USA; Epivir, GlaxoSmithKline, Middlesex, United Kingdom and Viramune, Boehringer Ingelheim, Ingelheim am Rhein, Germany.
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