Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin

NCT00785980 | Completed Phase 1 Results

• 1 other identifier: MPC-001-08-1027
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

quinine sulfate; ciprofloxacin; drug interactions; cytochrome p450; male; female; adult; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration(Cmax)

  The maximum or peak concentration that the drug reaches in the plasma.

  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.

• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

  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.

  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.

• Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].

  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.

  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.

Study Arms (2)

Quinine Sulfate

ACTIVE COMPARATOR

Baseline quinine sulfate pharmacokinetics

Drug: Quinine Sulfate Capsules 324 mg

Quinine Sulfate with Ciprofloxacin

EXPERIMENTAL

Quinine sulfate pharmacokinetics in the presence of steady state ciprofloxacin

Drug: Ciprofloxacin 500 mg; Drug: Quinine Sulfate Capsules 324 mg

Interventions

Quinine Sulfate Capsules 324 mg DRUG

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.

Also known as: Qualaquin®

Quinine Sulfate

Ciprofloxacin 500 mg DRUG

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.

Also known as: Cipro®

Quinine Sulfate with Ciprofloxacin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Quinine; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Anthony R Godfrey, PharmD

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 7, 2012
• Results First Posted: October 21, 2009

Record last verified: 2012-07