Status:
COMPLETED
Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
In a prior in vitro study using human hepatocytes quinine was shown to induce the activity of Cytochrome p450 CYP 1A2. The present study will evaluate the extent to which quinine sulfate-related induc...
Detailed Description
This study will evaluate the effect of steady-state quinine sulfate on the pharmacokinetics of single dose theophylline and the effect of single dose theophylline on the pharmacokinetics of steady-sta...
Eligibility Criteria
Inclusion
- Medically healthy non-smoking, non-obese (≥ 55kg and within 15% of ideal body weight) adult male volunteers 18-45 years of age
Exclusion
- Subjects with history or presence of glucose 6 phosphate dehydrogenase deficiency, myasthenia gravis, optic neuritis, glaucoma or significant cardiovascular disease (including hypotension, 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 and/or P-glycoprotein within 30 days prior to the first dose and throughout 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 or have hypersensitivity to quinine sulfate, mefloquine, quinidine or hypersensitivity to theophylline or aminophylline.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00779259
Start Date
August 1 2007
End Date
September 1 2007
Last Update
October 28 2009
Active Locations (1)
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1
PRACS Institute
Fargo, North Dakota, United States, 58104