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

NCT01100060 | Completed Phase 1

• 1 other identifier: A0661195
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria Prophylaxis

Keywords

Azithromycin; chloroquine; microsphere; pharmacokinetics; bioavailability

Outcome Measures

Primary Outcomes (1)

• AUClast of azithromycin and chloroquine

  Through Day 5

Secondary Outcomes (2)

• Tmax and Cmax of azithromycin and chloroquine.

  Through Day 5

• AUClast, Tmax, and Cmax of desethylchloroquine.

  Through Day 5

Study Arms (2)

Group 1

EXPERIMENTAL

Co-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1.

Drug: azithromycin (AZ) microsphere; Drug: test chloroquine (CQ) formulation

Group 2

ACTIVE COMPARATOR

Co-administer the individual tablets of CQ 2 x 500 mg (600 mg CQ base) tablets plus AZ IR 4 x 500 mg tablets on Day 1.

Drug: azithromycin (AZ); Drug: chloroquine (CQ)

Interventions

azithromycin (AZ) microsphere DRUG

AZ microsphere (2000 mg) single dose on Day 1.

Also known as: Zmax

Group 1

test chloroquine (CQ) formulation DRUG

Test CQ formulation, 620 mg CQ base, single dose on Day 1.

Group 1

azithromycin (AZ) DRUG

AZ IR 4 x 500 mg tablets, single dose on Day 1.

Also known as: Zithromax

Group 2

chloroquine (CQ) DRUG

CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1

Also known as: Aralen

Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Azithromycin; Microspheres; Dosage Forms; Chloroquine

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Equipment and Supplies; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: April 8, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 25, 2010

Record last verified: 2010-08

Locations

US (1)