Drug Interaction Between Irbesartan and Hydrochlorothiazide

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01858610

Enrollment

Registered

2013-05-21

Start date

2013-03-31

Completion date

2013-04-30

Last updated

2013-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Fixed dose combination, Pharmacokinetics, Irbesartan, Hydrochlorothiazide, Pharmacodynamics, Normotensive Participants

Brief summary

This study was conducted to investigate any potential reaction between irbesartan and hydrochlorothiazide.

Interventions

DRUGIrbeasartan/hydrochlorothiazide

DRUGIrbesartan

DRUGHydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026