Drug Interaction Study of Azithromycin and Theophylline

NCT02023554 | Completed DMC

• 1 other identifier: 81302846-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease; Asthma

Keywords

azithromycin; theophylline; CYP3A4

Outcome Measures

Primary Outcomes (1)

• steady-state plasma concentration of theophylline

  Theophylline and it's metabolite(1,3-dimethyluric) blood concentration

  blood samples for theophylline will be collected on Days 8 and 15 before dosing

Study Arms (2)

Theophylline with azithromycin

EXPERIMENTAL

steady-state plasma concentration of theophylline in the presence of azithromycin

Drug: Theophylline with azithromycin

Theophylline alone

ACTIVE COMPARATOR

steady-state plasma concentration of theophylline alone

Drug: Theophylline alone

Interventions

Theophylline with azithromycin DRUG

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.

Theophylline with azithromycin

Theophylline alone DRUG

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.

Theophylline alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with COPD or asthma，aged 18-75 years;
• regularly visiting our hospital;
• meeting the indications for azithromycin and theophylline simultaneously;

You may not qualify if:

• patients with renal or hepatic dysfunction;
• patients with congestive heart failure;
• patients with hypothyroidism or hyperthyroidism;
• patients taking drugs likely to affect the theophylline metabolism in the preceding week;
• patients with severe chronic obstructive pulmonary disease,asthma or respiratory infection;

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Theophylline; Azithromycin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Liqing Wang, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

CN (1)