Overview

Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
Male
Summary
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).
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Damanhour University
Treatments:
Hydrochlorothiazide
Valsartan
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.