Back to resultsA Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine (AZCQ)
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fixed combination of Azithromycin and Chloroquine
Azithromycin and Chloroquine
Sponsored by
About this trial
This is an interventional health services research trial for Malaria focused on measuring Bioavailability
Eligibility Criteria
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of febrile illness within 5 days prior to first dose.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment A
Treatment B
Arm Description
Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.
A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.
Outcomes
Primary Outcome Measures
AUClast and Cmax of azithromycin and chloroquine for each treatment.
Secondary Outcome Measures
Tmax of azithromycin and chloroquine for each treatment cohort.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00844207
Brief Title
A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine
Acronym
AZCQ
Official Title
A Phase 1, Open Label, Randomized, Single Dose, Parallel Group Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine In Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Bioavailability
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Description
A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.
Intervention Type
Drug
Intervention Name(s)
Fixed combination of Azithromycin and Chloroquine
Intervention Description
Pfizer will provide the study medications, fixed combination azithromycin/chloroquine tablets (250 mg/155 mg, base), The study treatment is single dose.
Intervention Type
Drug
Intervention Name(s)
Azithromycin and Chloroquine
Intervention Description
Pfizer will provide Zithromax (500 mg) and Aralen (500 mg containing 300 mg chloroquine base). The study treatment is single dose.
Primary Outcome Measure Information:
Title
AUClast and Cmax of azithromycin and chloroquine for each treatment.
Time Frame
up to 96 hours post dose on Day 5
Secondary Outcome Measure Information:
Title
Tmax of azithromycin and chloroquine for each treatment cohort.
Time Frame
up to 96 hours post dose on Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
History of febrile illness within 5 days prior to first dose.
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661186&StudyName=A%20Phase%201%20Study%20To%20Estimate%20The%20Relative%20Bioavailability%20Of%20Fixed%20Combination%20Tablets%20Of%20Azithromycin%20And%20Chloroquine%20Compared%20To%20Co-Adm
Description
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Learn more about this trial
A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine
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