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

Study Overview
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Brief Summary
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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
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Evaluate the relative bioavailability, assessment of the safety and tolerability of azithromycin microsphere and the chloroquine test formulation compared to immediate release individual tablets.

Official Title
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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

Conditions
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Malaria Prophylaxis

Intervention / Treatment
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* Drug: azithromycin (AZ) microsphere
* Drug: test chloroquine (CQ) formulation
* Drug: azithromycin (AZ)
* Drug: chloroquine (CQ)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1. | Drug: azithromycin (AZ) microsphere<br>* AZ microsphere (2000 mg) single dose on Day 1.<br>* Other names: Zmax;Drug: test chloroquine (CQ) formulation<br>* Test CQ formulation, 620 mg CQ base, single dose on Day 1.<br>|
| Active Comparator: Group 2<br>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. | Drug: azithromycin (AZ)<br>* AZ IR 4 x 500 mg tablets, single dose on Day 1.<br>* Other names: Zithromax;Drug: chloroquine (CQ)<br>* CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1<br>* Other names: Aralen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of azithromycin and chloroquine |  | Through Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax and Cmax of azithromycin and chloroquine. |  | Through Day 5 | 
| AUClast, Tmax, and Cmax of desethylchloroquine. |  | Through Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Azithromycin, chloroquine, microsphere, pharmacokinetics, bioavailability