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Drug Interaction Study of Azithromycin and Theophylline

NCT02023554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-08-19

No results posted yet for this study

Summary

Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere with the pharmacokinetics of many other drugs that are metabolised by this enzyme like theophylline.The aim of this study is to determine whether azithromycin can effect theophylline metabolism in patients.

Conditions

Interventions

DRUG

Theophylline with azithromycin

Drug: Theophylline(100mg,sustained release tablets). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 1 to day 7. Drug:Azithromycin(250mg, capsules). Multi-dose of azithromycin(500mg,once daily) will administered at 8 pm from day 1 to day 7.

DRUG

Theophylline alone

Drug: Theophylline(100mg,sustained release tablet). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 8 to day 14.

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Liqing Wang, Doctor · Zhujiang Hospital,Southern Medical Unversity

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT02023554 on ClinicalTrials.gov