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 - Full Text View

Purpose

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	Intervention	Phase
Malaria	Drug: Fixed combination of Azithromycin and Chloroquine Drug: Azithromycin and Chloroquine	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Chloroquine phosphate Chloroquine Chloroquine sulfate Chloroquine hydrochloride Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

AUClast and Cmax of azithromycin and chloroquine for each treatment. [ Time Frame: up to 96 hours post dose on Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tmax of azithromycin and chloroquine for each treatment cohort. [ Time Frame: up to 96 hours post dose on Day 5 ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	February 2009
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844207

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00844207 History of Changes
Other Study ID Numbers:	A0661186
Study First Received:	February 10, 2009
Last Updated:	April 20, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Bioavailability

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Azithromycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013

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 (AZCQ)