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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria Prophylaxis
Intervention: azithromycin (AZ) microsphere (Drug); test chloroquine (CQ) formulation (Drug); azithromycin (AZ) (Drug); chloroquine (CQ) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: AUClast of azithromycin and chloroquine
Secondary outcome: Tmax and Cmax of azithromycin and chloroquine.AUClast, Tmax, and Cmax of desethylchloroquine.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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).
- 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.
Locations and Contacts
Pfizer Investigational Site, New Haven, Connecticut 06511, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2010
Last updated: August 24, 2010
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