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)

• ClinicalTrials.gov Identifier: NCT00844207
• Recruitment Status: Completed
• First Posted: February 16, 2009
• Last Update Posted: April 21, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: February 10, 2009
• First Posted Date: February 16, 2009
• Last Update Posted Date: April 21, 2009
• Study Start Date: February 2009
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 12, 2009): AUClast and Cmax of azithromycin and chloroquine for each treatment. [ Time Frame: up to 96 hours post dose on Day 5 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 12, 2009): Tmax of azithromycin and chloroquine for each treatment cohort. [ Time Frame: up to 96 hours post dose on Day 5 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Malaria

Intervention

• 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.

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 12, 2009): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00844207
• Other Study ID Numbers: A0661186
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2009