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

Phase 1

Completed

• Conditions: Malaria
• Interventions: Drug: Fixed combination of Azithromycin and Chloroquine; Drug: Azithromycin and Chloroquine

• Registration Number: NCT00844207
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-16
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-20
• Last Update Posted: 2009-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A	Fixed combination of Azithromycin and Chloroquine	Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.
Treatment B	Azithromycin and Chloroquine	A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.

Primary Outcome Measures

Name	Time	Method
AUClast and Cmax of azithromycin and chloroquine for each treatment.	up to 96 hours post dose on Day 5

Secondary Outcome Measures

Name	Time	Method
Tmax of azithromycin and chloroquine for each treatment cohort.	up to 96 hours post dose on Day 5

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States