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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-08-25

No results posted yet for this study

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

Interventions

DRUG

azithromycin (AZ) microsphere

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

DRUG

test chloroquine (CQ) formulation

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

DRUG

azithromycin (AZ)

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

DRUG

chloroquine (CQ)

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100060 on ClinicalTrials.gov