Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)

NCT ID: NCT01767298

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-12-31

Brief 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).

Conditions

Healthy Normotensive Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Valsartan 320 mg alone

Valsartan alone

Group Type: OTHER

Valsartan

Intervention Type: DRUG

Valsartan alone

Hydrochlorothiazide 25 mg alone

Hydrochlorothiazide alone

Group Type: OTHER

Hydrochlorothiazide

Intervention Type: DRUG

Hydrochlorothiazide alone

Valsartan 320 mg + Hydrochlorothiazide 25 mg

Concomitant administration of valsartan 320 mg + Hydrochlorothiazide 25 mg

Group Type: OTHER

Valsartan/Hydrochlorothiazide

Intervention Type: DRUG

Co-administration or fixed dose combination

Valsartan / Hydrochlorothiazide 320 mg/25mg

Fixed dose combination of valsartan 320 mg + Hydrochlorothiazide 25 mg

Group Type: OTHER

Valsartan/Hydrochlorothiazide

Intervention Type: DRUG

Co-administration or fixed dose combination

Interventions

Valsartan/Hydrochlorothiazide

Co-administration or fixed dose combination

Intervention Type: DRUG

Valsartan

Valsartan alone

Intervention Type: DRUG

Hydrochlorothiazide

Hydrochlorothiazide alone

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Sally Helmy, PhD, CPHQ

Lecturer of Pharmaceutics, Faculty of Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PPT1 PART II

Identifier Type: -

Identifier Source: org_study_id