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

This study has been completed.
Information provided by (Responsible Party):
Sally Helmy, PhD, CPHQ, Damanhour University Identifier:
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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: 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 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


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
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No Contacts or Locations Provided
  More Information

Responsible Party: Sally Helmy, PhD, CPHQ, Lecturer of Pharmaceutics, Faculty of Pharmacy, Damanhour University Identifier: NCT01767298     History of Changes
Other Study ID Numbers: PPT1 PART II
Study First Received: January 10, 2013
Last Updated: January 10, 2013

Keywords provided by Damanhour University:
Fixed dose combination

Additional relevant MeSH terms:
Antihypertensive Agents
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 processed this record on April 28, 2017