Drug Interaction Between Irbesartan and Hydrochlorothiazide

Study Overview
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Brief Summary
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This study was conducted to investigate any potential reaction between irbesartan and hydrochlorothiazide.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Irbeasartan/hydrochlorothiazide
* Drug: Irbesartan
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Irbesartan alone<br>Irbesartan 300 mg alone | Drug: Irbesartan<br> <br> |
| Other: Hydrochlorothiazide 25 mg alone<br>Hydrochlorothiazide 25 mg alone | Drug: Hydrochlorothiazide<br> <br> |
| Other: Irbesartan 300 mg + Hydrochlorothiazide 25 mg<br>Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination | Drug: Irbeasartan/hydrochlorothiazide<br> <br> * Other names: Fixed dose combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fixed dose combination, Pharmacokinetics, Irbesartan, Hydrochlorothiazide, Pharmacodynamics, Normotensive Participants