Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (PKVH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sally Helmy, PhD, CPHQ, Damanhour University
ClinicalTrials.gov Identifier:
NCT01767259
First received: January 8, 2013
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
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

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. ] [ Designated as safety issue: Yes ]
    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 160 mg alone
Valsartan alone
Drug: Valsartan
Valsartan alone
Hydrochlorothiazide 12.5 mg alone
Hydrochlorothiazide alone
Drug: Hydrochlorothiazide
Hydrochlorothiazide alone
Valsartan160 mg + Hydrochlorothiazide12.5 mg
Concomitant administration of valsartan 160 mg + Hydrochlorothiazide 12.5 mg
Drug: Valsartan/Hydrochlorothiazide
Co-administration or fixed dose combination
Other Names:
  • Fixed dose combination
  • Pharmacokinetic interaction
Valsartan / Hydrochlorothiazide 160 mg/12.5mg
Fixed dose combination of valsartan 160 mg + Hydrochlorothiazide 12.5 mg
Drug: Valsartan/Hydrochlorothiazide
Co-administration or fixed dose combination
Other Names:
  • Fixed dose combination
  • Pharmacokinetic interaction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767259

Locations
Egypt
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Damanhour, Egypt
Sponsors and Collaborators
Damanhour University
Investigators
Principal Investigator: Sally Helmy, PhD, CPHQ Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt
  More Information

No publications provided

Responsible Party: Sally Helmy, PhD, CPHQ, Lecturer of Pharmaceutics, Faculty of Pharmacy, Damanhour University
ClinicalTrials.gov Identifier: NCT01767259     History of Changes
Other Study ID Numbers: PPT1
Study First Received: January 8, 2013
Last Updated: January 12, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Damanhour University:
Fixed dose combination
Pharmacokinetics
Valsartan
Hydrochlorothiazide

Additional relevant MeSH terms:
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
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

ClinicalTrials.gov processed this record on August 28, 2014