sulfamethoxazole + placebo

"Sulfamethoxazole + placebo" refers to a specific control arm intervention used in a Phase 1, randomized, open-label, crossover drug interaction study (NCT01418365) sponsored by Shire (now Takeda). In this trial, healthy adult subjects received a combination of sulfamethoxazole (800 mg) and trimethoprim (160 mg) twice daily, co-administered with a placebo matching the MMX mesalazine (Lialda/Mezavant) formulation. The primary objective of this arm was to establish the baseline pharmacokinetic profile of sulfamethoxazole when given without the active mesalazine component, thereby allowing researchers to determine if mesalazine alters the metabolism or excretion of the antibiotic. Sulfamethoxazole itself is a sulfonamide antibiotic that competitively inhibits the bacterial enzyme dihydropteroate synthase, a key step in the folate synthesis pathway, and is almost always used in combination with trimethoprim to provide synergistic antibacterial activity.

Other names

Sulfamethoxazole administered alone