A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to estimate the relative bioavailability of fixed azithromycin / chloroquine combination tablets relative to co-administered individual tablets of azithromycin and chloroquine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Azithromycin; Chloroquine; Chloroquine diphosphate

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).

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.

• Any condition possibly affecting drug absorption (eg, gastrectomy).

• A positive urine drug screen.