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. |
ClinicalTrials.gov Identifier: NCT01767259 |
Recruitment Status :
Completed
First Posted : January 14, 2013
Last Update Posted : January 15, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Normotensive Participants | Drug: Valsartan/Hydrochlorothiazide Drug: Valsartan Drug: Hydrochlorothiazide | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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:
|
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:
|
- 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.

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, Learn About Clinical Studies.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767259
Egypt | |
Pharmaceutics Department, Faculty of Pharmacy, Damanhour University | |
Damanhour, Egypt |
Principal Investigator: | Sally Helmy, PhD, CPHQ | Pharmaceutics Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt |
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 |
First Posted: | January 14, 2013 Key Record Dates |
Last Update Posted: | January 15, 2013 |
Last Verified: | January 2013 |
Fixed dose combination Pharmacokinetics Valsartan Hydrochlorothiazide |
Valsartan Hydrochlorothiazide Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |