A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects
NCT ID: NCT01100060
Last Updated: 2010-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2010-04-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Group 1
Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1.
azithromycin (AZ) microsphere
AZ microsphere (2000 mg) single dose on Day 1.
test chloroquine (CQ) formulation
Test CQ formulation, 620 mg CQ base, single dose on Day 1.
Group 2
Co-administer the individual tablets of CQ 2 x 500 mg (600 mg CQ base) tablets plus AZ IR 4 x 500 mg tablets on Day 1.
azithromycin (AZ)
AZ IR 4 x 500 mg tablets, single dose on Day 1.
chloroquine (CQ)
CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
Interventions
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azithromycin (AZ) microsphere
AZ microsphere (2000 mg) single dose on Day 1.
test chloroquine (CQ) formulation
Test CQ formulation, 620 mg CQ base, single dose on Day 1.
azithromycin (AZ)
AZ IR 4 x 500 mg tablets, single dose on Day 1.
chloroquine (CQ)
CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
* History of febrile illness within 5 days prior to first dose.
* Treatment with azithromycin within the past 30 days or with chloroquine within the past 45 days.
* Known immediate family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death. "Immediate" is considered "first degree".
* Known allergy to macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin) or chloroquine (or other 4 aminoquinolines) or severe allergic reaction to any drug in the past (eg, difficulty breathing, anaphylaxis).
* History of intolerance to azithromycin or chloroquine.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0661195
Identifier Type: -
Identifier Source: org_study_id
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