Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
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| ClinicalTrials.gov Identifier: NCT00785980 |
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Recruitment Status :
Completed
First Posted : November 5, 2008
Results First Posted : October 21, 2009
Last Update Posted : August 7, 2012
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Sponsor:
Mutual Pharmaceutical Company, Inc.
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.
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Brief Summary:
Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Drug: Quinine Sulfate Capsules 324 mg Drug: Ciprofloxacin 500 mg | Phase 1 |
Ciprofloxacin is moderate inhibitor of cytochrome P450 1A2 (CYP1A2), one of the enzymes responsible for the metabolism of quinine. This study will evaluate the effect of ciprofloxacin-related inhibition of CYP1A2 on the pharmacokinetics of quinine sulfate. In the morning on study Day 1 after a fast of at least 10 hours, twenty-four healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 will be given one oral dose of quinine sulfate (2 x 324 mg capsules). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 36 hours post-dose at times sufficient to adequately define the pharmacokinetics of quinine sulfate. A 7-day washout period will be completed after the first dose of quinine sulfate on Day 1. Beginning at 07:45 am on Day 8 and continuing through Day 10, all subjects will return to the clinic for non-confined dosing of ciprofloxacin (1 x 500 mg tablet) every 12 hours. Administered ciprofloxacin doses on these days will not be in a fasted state. At 07:45 am on Day 11 after a fast of at least 10 hours, all study participants will receive a co-administered single oral dose of quinine sulfate (2 x 324 mg capsules) and ciprofloxacin (1 x 500 mg tablet). A final dose of ciprofloxacin (1 x 500 mg tablet) will be administered 12 hours later. Blood samples will be drawn from all participants before dosing and for 36 hours post-dose at times sufficient to adequately define the pharmacokinetics of quinine sulfate. Fasting will continue for 4 hours following the co-administered dose of quinine sulfate and ciprofloxacin. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured pre-dose and at 1, 2 and 3 hours post-dose on Days 1 and 11. An electrocardiogram (ECG) will be done pre-dose and at 1, 2 and 4 hours post-dose on Days 1 and 11. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | A One-Directional, Open-Label Drug Interaction Study to Investigate the Effects of Multiple-Dose Ciprofloxacin HCl on the Single-Dose Pharmacokinetics of Quinine in Healthy Volunteers |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | October 2008 |
| Actual Study Completion Date : | October 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Drug Reactions
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Quinine Sulfate
Baseline quinine sulfate pharmacokinetics
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Drug: Quinine Sulfate Capsules 324 mg
A single dose of quinine sulfate (2 x 324 mg capsules) administered on the morning of Day 1 after an overnight fast of at least 10 hours.
Other Name: Qualaquin® |
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Experimental: Quinine Sulfate with Ciprofloxacin
Quinine sulfate pharmacokinetics in the presence of steady state ciprofloxacin
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Drug: Ciprofloxacin 500 mg
A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.
Other Name: Cipro® Drug: Quinine Sulfate Capsules 324 mg A single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) in the morning on Day 11 after an overnight fast of at least 10 hours.
Other Name: Qualaquin® |
Primary Outcome Measures :
- Maximum Plasma Concentration(Cmax) [ Time Frame: Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose. ]The maximum or peak concentration that the drug reaches in the plasma.
- Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose. ]The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.
- Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]. [ Time Frame: Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose. ]The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy adults 18-45 years of age
- Non-smoking
- Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
- Body mass index (BMI)between 18 and 32
- Medically healthy on the basis of medical history and physical examination
- Hemoglobin > or = to 11.5 g/dL
- Completion of the screening process within 28 days prior to dosing
- Provision of voluntary written informed consent
Exclusion Criteria:
- Recent participation (within 28 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Recent (2-year) history or evidence of alcoholism or drug abuse
- History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
- Drug allergies to mefloquine or quinidine
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785980
Sponsors and Collaborators
Mutual Pharmaceutical Company, Inc.
Investigators
| Principal Investigator: | Anthony R Godfrey, PharmD | PRACS Institute, Ltd. |
Additional Information:
| Responsible Party: | Mutual Pharmaceutical Company, Inc. |
| ClinicalTrials.gov Identifier: | NCT00785980 |
| Other Study ID Numbers: |
MPC-001-08-1027 |
| First Posted: | November 5, 2008 Key Record Dates |
| Results First Posted: | October 21, 2009 |
| Last Update Posted: | August 7, 2012 |
| Last Verified: | July 2012 |
Keywords provided by Mutual Pharmaceutical Company, Inc.:
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quinine sulfate ciprofloxacin drug interactions cytochrome p450 |
male female adult pharmacokinetics |
Additional relevant MeSH terms:
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Ciprofloxacin Quinine Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |
Antimalarials Antiprotozoal Agents Antiparasitic Agents Muscle Relaxants, Central Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents |