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)

Pfizer

Status and phase

Completed

Phase 1

Conditions

Malaria Prophylaxis

Treatments

Drug: test chloroquine (CQ) formulation

Drug: chloroquine (CQ)

Drug: azithromycin (AZ) microsphere

Drug: azithromycin (AZ)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01100060

A0661195

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.