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Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)

Information source: Damanhour University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Normotensive Participants

Intervention: Valsartan/Hydrochlorothiazide (Drug); Valsartan (Drug); Hydrochlorothiazide (Drug)

Phase: N/A

Status: Completed

Sponsored by: Damanhour University


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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Tolerability


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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


- 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.

Locations and Contacts

Additional Information

Starting date: October 2012
Last updated: January 10, 2013

Page last updated: August 23, 2015

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