Drug Interaction Between Irbesartan and Hydrochlorothiazide
1 other identifier
interventional
18
1 country
1
Brief Summary
This study was conducted to investigate any potential reaction between irbesartan and hydrochlorothiazide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Mar 2013
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 12, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedMay 27, 2013
May 1, 2013
1 month
May 12, 2013
May 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Blood pressure (systolic/diastolic)
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide
After collection of all blood samples, an expected average of 4 weeks
Heart rate
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide
After collection of all blood samples, an expected average of 4 weeks
Study Arms (3)
Irbesartan alone
OTHERIrbesartan 300 mg alone
Hydrochlorothiazide 25 mg alone
OTHERHydrochlorothiazide 25 mg alone
Irbesartan 300 mg + Hydrochlorothiazide 25 mg
OTHERIrbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination
Interventions
Eligibility Criteria
You may qualify if:
- At least 18 years old and not more than 45 healthy normotensive male volunteers Who had passed all the screening parameters
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Damanhur, Egypt
Related Publications (1)
Hedaya MA, Helmy SA. Modeling of the pharmacokinetic/pharmacodynamic interaction between irbesartan and hydrochlorothiazide in normotensive subjects. Biopharm Drug Dispos. 2015 May;36(4):216-31. doi: 10.1002/bdd.1935. Epub 2015 Feb 4.
PMID: 25545238DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Pharmaceutics, Faculty of Pharmacy
Study Record Dates
First Submitted
May 12, 2013
First Posted
May 21, 2013
Study Start
March 1, 2013
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
May 27, 2013
Record last verified: 2013-05