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Trial record 1 of 1 for:    NCT01100060
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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 (AZCQ)

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ClinicalTrials.gov Identifier: NCT01100060
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE April 8, 2010
Last Update Posted Date August 25, 2010
Study Start Date  ICMJE April 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2010)
AUClast of azithromycin and chloroquine [ Time Frame: Through Day 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01100060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2010)
  • Tmax and Cmax of azithromycin and chloroquine. [ Time Frame: Through Day 5 ]
  • AUClast, Tmax, and Cmax of desethylchloroquine. [ Time Frame: Through Day 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Phase 1, Open-Label, Randomized, Single Dose, Parallel Design Study To Estimate The Relative Bioavailability Of Co Administered Formulations Of Azithromycin Microsphere (AZ) And Chloroquine Test Formulation (CQ) Compared With Co Administered Immediate Release Individual AZ And CQ Tablets In Healthy Adult Subjects
Brief Summary Estimate the relative bioavailability of co-administered azithromycin microsphere (2000 mg) and the chloroquine (620 mg CQ base) test formulation compared to co-administered immediate release individual tablets of azithromycin (2000 mg) and chloroquine (600 mg CQ base) in healthy adult subjects.
Detailed Description Evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Malaria Prophylaxis
Intervention  ICMJE
  • Drug: azithromycin (AZ) microsphere
    AZ microsphere (2000 mg) single dose on Day 1.
    Other Name: Zmax
  • Drug: test chloroquine (CQ) formulation
    Test CQ formulation, 620 mg CQ base, single dose on Day 1.
  • Drug: azithromycin (AZ)
    AZ IR 4 x 500 mg tablets, single dose on Day 1.
    Other Name: Zithromax
  • Drug: chloroquine (CQ)
    CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
    Other Name: Aralen
Study Arms  ICMJE
  • Experimental: Group 1
    Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1.
    Interventions:
    • Drug: azithromycin (AZ) microsphere
    • Drug: test chloroquine (CQ) formulation
  • Active Comparator: 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.
    Interventions:
    • Drug: azithromycin (AZ)
    • Drug: chloroquine (CQ)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
  • 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:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01100060
Other Study ID Numbers  ICMJE A0661195
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2010

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