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This study was conducted to investigate any potential reaction between irbesartan and hydrochlorothiazide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irbesartan alone | Other | Irbesartan 300 mg alone |
|
| Hydrochlorothiazide 25 mg alone | Other | Hydrochlorothiazide 25 mg alone |
|
| Irbesartan 300 mg + Hydrochlorothiazide 25 mg | Other | Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbeasartan/hydrochlorothiazide | Drug |
|
| |
| 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 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutics Department, Faculty of Pharmacy, Damanhour University | Damanhur | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25545238 | Derived | 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. |
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| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| Irbesartan |
| Drug |
|
| Hydrochlorothiazide | Drug |
|
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011083 | Polycyclic Compounds |