You are here

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

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Malaria Prophylaxis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01100060
Pfizer
Completed
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
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 SummaryEstimate 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 DescriptionEvaluate 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 DateJune 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now