Drug Interaction Study of Azithromycin and Theophylline
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|ClinicalTrials.gov Identifier: NCT02023554|
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease Asthma||Drug: Theophylline with azithromycin Drug: Theophylline alone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Azithromycin on the Steady-State Plasma Levels of Theophylline in a Chinese Population|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Theophylline with azithromycin
steady-state plasma concentration of theophylline in the presence of azithromycin
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.
Active Comparator: Theophylline alone
steady-state plasma concentration of theophylline alone
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.
- steady-state plasma concentration of theophylline [ Time Frame: blood samples for theophylline will be collected on Days 8 and 15 before dosing ]Theophylline and it's metabolite(1,3-dimethyluric) blood concentration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023554
|Zhujiang Hospital,Southern Medical Universtiy|
|Guangzhou, Guangdong, China, 510282|
|Principal Investigator:||Liqing Wang, Doctor||Zhujiang Hospital,Southern Medical Unversity|