Status:
COMPLETED
Drug-Drug Interaction Study of Qualaquin and Midazolam
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is an open label non-randomized single sequence, single group two way drug interaction study in healthy adult volunteers to determine the extent to which quinine, an inducer of cytochrome p450 CY...
Detailed Description
This is an open label single sequence single group non-randomized two way drug interaction study in healthy adult volunteers to determine the extent to which quinine, an inducer of cytochrome p450 CYP...
Eligibility Criteria
Inclusion
- Medically healthy non-smoking, non-obese (≥ 60 kg males, ≥52 kg females within 15% of IBW) adult volunteers 18-45 years of age
Exclusion
- Subjects with history or presence of significant cardiovascular disease (including hypotension, hypertension, bradycardia or EKG abnormalities), pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or an active sexually transmitted disease.
- Subjects with significant blood loss in the prior 56 days, plasma donation within 7 days , hemoglobin \< 12.0 g/dl or who have participated in another clinical trial within the prior 30 days.
- Subjects with recent (2-year) history or evidence of alcoholism or drug abuse.
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome P450 (CYP) enzymes 10 days or 28 days respectively prior to the first dose and throughout the study.
- Subjects who have received monoamine oxidase inhibitors or been on a special diet within 28 days of starting the study.
- Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
- Subjects who are pregnant or lactating, taking hormone replacement therapy or have known allergies to quinine sulfate, mefloquine, quinidine or midazolam and other benzodiazepines.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00785486
Start Date
March 1 2007
End Date
March 1 2007
Last Update
August 31 2012
Active Locations (1)
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1
MDS Pharma Services
Phoenix, Arizona, United States, 85044