- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767298
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses) (PKVH PART II)
January 10, 2013 updated by: Sally Helmy, PhD, CPHQ, Damanhour University
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide: An Open-Label, Randomized, Four-Period Crossover Study in Healthy Egyptian Male Volunteers (PART II)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Valsartan 320 mg alone
Valsartan alone
|
Valsartan alone
|
OTHER: Hydrochlorothiazide 25 mg alone
Hydrochlorothiazide alone
|
Hydrochlorothiazide alone
|
OTHER: Valsartan 320 mg + Hydrochlorothiazide 25 mg
Concomitant administration of valsartan 320 mg + Hydrochlorothiazide 25 mg
|
Co-administration or fixed dose combination
|
OTHER: Valsartan / Hydrochlorothiazide 320 mg/25mg
Fixed dose combination of valsartan 320 mg + Hydrochlorothiazide 25 mg
|
Co-administration or fixed dose combination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Participants will be followed for the duration of study, an expected average of 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
January 10, 2013
First Submitted That Met QC Criteria
January 10, 2013
First Posted (ESTIMATE)
January 14, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 14, 2013
Last Update Submitted That Met QC Criteria
January 10, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Valsartan
- Hydrochlorothiazide
Other Study ID Numbers
- PPT1 PART II
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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