AZCQ: 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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00844207

Collaborator

(none)

Enrollment

Location

Arms

1.9

Duration (Months)

20.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Fixed combination of Azithromycin and Chloroquine Drug: Azithromycin and Chloroquine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

A Phase 1, Open Label, Randomized, Single Dose, Parallel Group Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine In Healthy Adult Subjects

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.	Drug: Fixed combination of Azithromycin and Chloroquine Pfizer will provide the study medications, fixed combination azithromycin/chloroquine tablets (250 mg/155 mg, base), The study treatment is single dose.
Active Comparator: Treatment B A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.	Drug: Azithromycin and Chloroquine Pfizer will provide Zithromax (500 mg) and Aralen (500 mg containing 300 mg chloroquine base). The study treatment is single dose.

Arm

Intervention/Treatment

Experimental: Treatment A

Two of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.

Drug: Fixed combination of Azithromycin and Chloroquine

Pfizer will provide the study medications, fixed combination azithromycin/chloroquine tablets (250 mg/155 mg, base), The study treatment is single dose.

Active Comparator: Treatment B

A single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.

Drug: Azithromycin and Chloroquine

Pfizer will provide Zithromax (500 mg) and Aralen (500 mg containing 300 mg chloroquine base). The study treatment is single dose.

Outcome Measures

Primary Outcome Measures

AUClast and Cmax of azithromycin and chloroquine for each treatment. [up to 96 hours post dose on Day 5]

Secondary Outcome Measures

Tmax of azithromycin and chloroquine for each treatment cohort. [up to 96 hours post dose on Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.