NCT01418365

Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone \& in combination with MMX® Mesalazine/mesalamine

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metronidazole + MMX Mesalazine/mesalamine placebo	Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally
DRUG	Metronidazole + MMX Mesalazine/mesalamine	Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally

Timeline

• Start date: 2011-08-22
• Primary completion: 2011-10-05
• Completion: 2011-10-05
• First posted: 2011-08-17
• Last updated: 2021-06-09
• Results posted: 2012-08-17

Locations

1 site across 1 country: United States