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Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses) (PKVH PART II)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 14, 2013
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sally Helmy, PhD, CPHQ, 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).

Condition Intervention
Healthy Normotensive Participants Drug: Valsartan/Hydrochlorothiazide Drug: Valsartan Drug: Hydrochlorothiazide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide: An Open-Label, Randomized, Four-Period Crossover Study in Healthy Egyptian Male Volunteers (PART II)

Resource links provided by NLM:

Further study details as provided by Sally Helmy, PhD, CPHQ, Damanhour University:

Primary Outcome Measures:
  • Tolerability [ Time Frame: Participants will be followed for the duration of study, an expected average of 6 weeks. ]
    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.

Enrollment: 24
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Valsartan 320 mg alone
Valsartan alone
Drug: Valsartan
Valsartan alone
Hydrochlorothiazide 25 mg alone
Hydrochlorothiazide alone
Drug: Hydrochlorothiazide
Hydrochlorothiazide alone
Valsartan 320 mg + Hydrochlorothiazide 25 mg
Concomitant administration of valsartan 320 mg + Hydrochlorothiazide 25 mg
Drug: Valsartan/Hydrochlorothiazide
Co-administration or fixed dose combination
Valsartan / Hydrochlorothiazide 320 mg/25mg
Fixed dose combination of valsartan 320 mg + Hydrochlorothiazide 25 mg
Drug: Valsartan/Hydrochlorothiazide
Co-administration or fixed dose combination


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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Sally Helmy, PhD, CPHQ, Lecturer of Pharmaceutics, Faculty of Pharmacy, Damanhour University
ClinicalTrials.gov Identifier: NCT01767298     History of Changes
Other Study ID Numbers: PPT1 PART II
First Submitted: January 10, 2013
First Posted: January 14, 2013
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by Sally Helmy, PhD, CPHQ, Damanhour University:
Fixed dose combination

Additional relevant MeSH terms:
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators