- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01858610
Drug Interaction Between Irbesartan and Hydrochlorothiazide
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Damanhour, Egypt
- Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Irbesartan alone
Irbesartan 300 mg alone
|
|
Other: Hydrochlorothiazide 25 mg alone
|
|
Other: Irbesartan 300 mg + Hydrochlorothiazide 25 mg
Irbesartan 300 mg + Hydrochlorothiazide 25 fixed dose combination
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure (systolic/diastolic)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
|
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
Time Frame: After collection of all blood samples, an expected average of 4 weeks
|
After collection of all blood samples, an expected average of 4 weeks
|
Heart rate
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
|
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
Time Frame: After collection of all blood samples, an expected average of 4 weeks
|
After collection of all blood samples, an expected average of 4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
- Irbesartan
Other Study ID Numbers
- PPT4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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