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Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (PKVH)

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. Identifier: NCT01767259
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):
Sally Helmy, PhD, CPHQ, Damanhour University

Tracking Information
First Submitted Date  ICMJE January 8, 2013
First Posted Date  ICMJE January 14, 2013
Last Update Posted Date January 15, 2013
Study Start Date  ICMJE October 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide
Official Title  ICMJE Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide: An Open-Label, Randomized, Four-Period Crossover Study in Healthy Egyptian Male Volunteers
Brief Summary This study was conducted to compare the rate and extent of absorption of valsartan and hydrochlorothiazide following oral administration as a fixed dose combination tablet and concomitant administration of the individual drugs under fasting conditions in healthy Egyptian subjects. The study was extended to investigate any potential reaction between VAL and HCT.
Detailed Description This study comprised 2 separate parts, I and II; each was a single-dose, open-label, 4-crossover periods separated by a 2 weeks washout, and 4-Treatments. Part I consisted of Treatments A (VAL 160 mg alone), B (HCT 12.5 mg alone), C (VAL 160 mg + HCT 12.5 mg) and D (VAL / HCT 160 mg/12.5mg) and Part II consisted of Treatments E (VAL 320 mg alone), F (HCT 25 mg alone), G (VAL 320 mg + HCT 25 mg) and H (VAL / HCT 320 mg/25 mg). Blood samples were collected up to 48 hours postdose and plasma was analyzed for VAL and HCT concentrations using HPLC. The pharmacokinetic properties of each drug after co-administration of VAL and HCT were compared with those of each drug administered alone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Normotensive Participants
Intervention  ICMJE
  • Drug: Valsartan/Hydrochlorothiazide
    Co-administration or fixed dose combination
    Other Names:
    • Fixed dose combination
    • Pharmacokinetic interaction
  • Drug: Valsartan
    Valsartan alone
  • Drug: Hydrochlorothiazide
    Hydrochlorothiazide alone
Study Arms  ICMJE
  • Valsartan 160 mg alone
    Valsartan alone
    Intervention: Drug: Valsartan
  • Hydrochlorothiazide 12.5 mg alone
    Hydrochlorothiazide alone
    Intervention: Drug: Hydrochlorothiazide
  • Valsartan160 mg + Hydrochlorothiazide12.5 mg
    Concomitant administration of valsartan 160 mg + Hydrochlorothiazide 12.5 mg
    Intervention: Drug: Valsartan/Hydrochlorothiazide
  • Valsartan / Hydrochlorothiazide 160 mg/12.5mg
    Fixed dose combination of valsartan 160 mg + Hydrochlorothiazide 12.5 mg
    Intervention: Drug: Valsartan/Hydrochlorothiazide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2013)
Original Actual Enrollment  ICMJE
 (submitted: January 10, 2013)
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01767259
Other Study ID Numbers  ICMJE PPT1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sally Helmy, PhD, CPHQ, Damanhour University
Study Sponsor  ICMJE Damanhour University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sally Helmy, PhD, CPHQ Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt
PRS Account Damanhour University
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP