Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)

Study Overview
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Brief Summary
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This study was conducted to compare the rate and extent of absorption of valsartan and hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).

Official Title
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Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide: An Open-Label, Randomized, Four-Period Crossover Study in Healthy Egyptian Male Volunteers (PART II)

Conditions
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Healthy Normotensive Participants

Intervention / Treatment
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* Drug: Valsartan/Hydrochlorothiazide
* Drug: Valsartan
* 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 male volunteers Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame Who had passed all the screening parameters Free of any drug exposure known to interfere with the pharmacokinetics or assay of fexofenadine for at least 10 days prior to the study Who had to be able to communicate effectively with study personnel, be literate, and able to give consent. 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 A history of serious intolerance, allergy, or sensitivity to fexofenadine The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) 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 Cannot follow instructions, in the opinion of the investigator.

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: Valsartan 320 mg alone<br>Valsartan alone | Drug: Valsartan<br>* Valsartan alone<br>|
| Other: Hydrochlorothiazide 25 mg alone<br>Hydrochlorothiazide alone | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide alone<br>|
| Other: Valsartan 320 mg + Hydrochlorothiazide 25 mg<br>Concomitant administration of valsartan 320 mg + Hydrochlorothiazide 25 mg | Drug: Valsartan/Hydrochlorothiazide<br>* Co-administration or fixed dose combination<br>|
| Other: Valsartan / Hydrochlorothiazide 320 mg/25mg<br>Fixed dose combination of valsartan 320 mg + Hydrochlorothiazide 25 mg | Drug: Valsartan/Hydrochlorothiazide<br>* Co-administration or fixed dose combination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study. | Participants will be followed for the duration of study, an expected average of 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fixed dose combination, Pharmacokinetics, Valsartan, Hydrochlorothiazide