Dose Selection Clause Samples

Dose Selection. Solosec is a potent, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that has been shown to be efficacious and well tolerated. Secnidazole has been available for many years in Europe and other countries outside of the US as a single, oral 2 g dose, used as either monotherapy or in combination with other drugs. The drug has been used and investigated as a single or multiple dose regimen for the treatment of amebiasis, giardiasis, trichomoniasis and BV; there is a plethora of published literature on the use of secnidazole (▇▇▇▇▇▇ 1996, ▇▇▇▇▇ 1978, ▇▇▇▇▇▇▇ 1988, ▇▇▇▇▇▇ 2012, Piato 1977, Roche 1977, Siboulet 1977, ▇▇▇▇▇▇ 1978). Data demonstrate that secnidazole is efficacious for the treatment of BV as well as other infections, including trichomoniasis. The efficacy profile of secnidazole coupled with the tolerable safety profile and convenience of the dosing regimen (i.e., 1 single oral dose) suggest that it is an attractive alternative to other drugs in this class. Clinical investigation of secnidazole in the US for the treatment of trichomoniasis is warranted.