Drug-Drug Interaction Study of Qualaquin and Midazolam

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

Conditions
Healthy
Interventions
DRUG

Midazolam Alone

Midazolam 2 mg syrup was given orally after a fast of at least 10 hours.

DRUG

Qualaquin (quinine) alone steady state

Qualaquin (quinine) 324 mg capsules were given orally every 8 hours for 7 days ( 21 doses total). On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen and fasting for at least 10 hours, all participants took their usual dose of Qualaquin (quinine). Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine at steady state

DRUG

Midazolam and Qualaquin at steady state

On the morning of day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen (324 mg every 8 hours), all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg after a fast of at least 10 hours

Trial Locations (1)

85044

MDS Pharma Services, Phoenix

All Listed Sponsors
lead

Mutual Pharmaceutical Company, Inc.

INDUSTRY

NCT00785486 - Drug-Drug Interaction Study of Qualaquin and Midazolam | Biotech Hunter | Biotech Hunter