NCT01469637

Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Sulfamethoxazole Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone \& in combination with Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	sulfamethoxazole + MMX placebo	800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4.
DRUG	Sulfamethoxazole + MMX Mesalazine/mesalamine	800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4

Timeline

• Start date: 2011-11-07
• Primary completion: 2011-12-20
• Completion: 2011-12-20
• First posted: 2011-11-10
• Last updated: 2021-07-13
• Results posted: 2012-10-25

Locations

1 site across 1 country: United States