Phase 1
N=24
Drug-Drug Interaction Study of Qualaquin and Midazolam
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00785486 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Maximum Serum Concentration (Cmax) — 12.0435; 4.6907; 4432.4089; 12.5585 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Midazolam Alone (Drug); Qualaquin (quinine) alone steady state (Drug); Midazolam and Qualaquin at steady state (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mutual Pharmaceutical Company, Inc.
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Serum Concentration (Cmax) |
12.0435; 4.6907; 4432.4089; 12.5585; 4.8605; 4399.7690 | — |
| PRIMARY Area Under the Concentration Time Curve From Zero to T (AUC 0-t) for Midazolam and 1-hydroxy Midazolam at Baseline and With Qualaquin (Quinine) at Steady State. |
30.076; 10.780; 27.242; 10.454 | — |
| PRIMARY Area Under the Concentration Time Curve From Zero to Infinity (AUC Inf) for Midazolam and 1 Hydroxy Midazolam Before (Day 1) and After (Day 10) Qualaquin (Quinine). |
31.324; 11.669; 28.771; 11.447 | — |
| PRIMARY The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam |
30455.4; 30568.7 | — |
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 CYP 3A4, affects the pharmacokinetics of midazolam, an accepted probe drug for CYP 3A4. The study will also determine the extent to which midazolam affects the pharmacokinetics of quinine.
Eligibility Criteria
Inclusion Criteria
- Medically healthy non-smoking, non-obese (≥ 60 kg males, ≥52 kg females within 15% of IBW) adult volunteers 18-45 years of age
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00785486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.