Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 22, 2011

Primary Completion Date

October 5, 2011

Study Completion Date

October 5, 2011

Conditions
Healthy
Interventions
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

Trial Locations (1)

Unknown

PRA International, Lenexa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY