Drug Interaction Between Irbesartan and Hydrochlorothiazide
Information source: Damanhour University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Irbeasartan/hydrochlorothiazide (Drug); Irbesartan (Drug); Hydrochlorothiazide (Drug)
Phase: N/A
Status: Completed
Sponsored by: Damanhour University
Summary
This study was conducted to investigate any potential reaction between irbesartan and
hydrochlorothiazide.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Blood pressure (systolic/diastolic)pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide Heart rate pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
At least 18 years old and not more than 45 healthy normotensive male volunteers Who had
passed all the screening parameters
Exclusion Criteria:
A clinically significant abnormal physical exam, medical history, or laboratory studies If
they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of >
95 or < 50 beats/min at screening The use of any prescription drug within the previous
month or use of any over-the-counter medication within the past 14 days A history of blood
dyscrasias A history of alcohol or drug abuse within the past year Donation of blood
during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of
completing the study Unable to tolerate vein puncture and multiple blood samplings Any
surgical/medical condition that might alter drug absorption, distribution, metabolism, or
excretion
Locations and Contacts
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt
Additional Information
Starting date: March 2013
Last updated: May 24, 2013
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