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 (AZCQ)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00844207
First received: February 10, 2009
Last updated: April 20, 2009
Last verified: April 2009

February 10, 2009
April 20, 2009
February 2009
April 2009   (final data collection date for primary outcome measure)
AUClast and Cmax of azithromycin and chloroquine for each treatment. [ Time Frame: up to 96 hours post dose on Day 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00844207 on ClinicalTrials.gov Archive Site
Tmax of azithromycin and chloroquine for each treatment cohort. [ Time Frame: up to 96 hours post dose on Day 5 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Malaria
  • Drug: Fixed combination of Azithromycin and Chloroquine
    Pfizer will provide the study medications, fixed combination azithromycin/chloroquine tablets (250 mg/155 mg, base), The study treatment is single dose.
  • Drug: Azithromycin and Chloroquine
    Pfizer will provide Zithromax (500 mg) and Aralen (500 mg containing 300 mg chloroquine base). The study treatment is single dose.
  • Experimental: Treatment A
    Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.
    Intervention: Drug: Fixed combination of Azithromycin and Chloroquine
  • Active Comparator: Treatment B
    A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.
    Intervention: Drug: Azithromycin and Chloroquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00844207
A0661186
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP