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Drug Interaction Between Irbesartan and Hydrochlorothiazide

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ClinicalTrials.gov Identifier: NCT01858610
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Sally Helmy, PhD, CPHQ, Damanhour University

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Irbeasartan/hydrochlorothiazide Drug: Irbesartan Drug: Hydrochlorothiazide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : March 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Irbesartan alone
Irbesartan 300 mg alone
Drug: Irbesartan
Hydrochlorothiazide 25 mg alone
Hydrochlorothiazide 25 mg alone
Drug: Hydrochlorothiazide
Irbesartan 300 mg + Hydrochlorothiazide 25 mg
Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination
Drug: Irbeasartan/hydrochlorothiazide
Other Name: Fixed dose combination




Primary Outcome Measures :
  1. Blood pressure (systolic/diastolic) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
  2. pharmacokinetic parameter such as the Cmax of irbesartan and hydrochlorothiazide [ Time Frame: After collection of all blood samples, an expected average of 4 weeks ]
  3. Heart rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
  4. pharmacokinetic parameter such as the AUC of irbesartan and hydrochlorothiazide [ Time Frame: After collection of all blood samples, an expected average of 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858610


Locations
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Egypt
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Damanhour, Egypt
Sponsors and Collaborators
Damanhour University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sally Helmy, PhD, CPHQ, Lecturer of Pharmaceutics, Faculty of Pharmacy, Damanhour University
ClinicalTrials.gov Identifier: NCT01858610     History of Changes
Other Study ID Numbers: PPT4
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by Sally Helmy, PhD, CPHQ, Damanhour University:
Fixed dose combination
Pharmacokinetics
Irbesartan
Hydrochlorothiazide
Pharmacodynamics
Normotensive Participants
Additional relevant MeSH terms:
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Hydrochlorothiazide
Irbesartan
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists