Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses) (PKVH PART II)

Damanhour University

Status: Completed

Conditions: Healthy Normotensive Participants

Treatments: Drug: Valsartan; Drug: Valsartan/Hydrochlorothiazide; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT01767298

PPT1 PART II

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

24 participants in 4 patient groups

Valsartan 320 mg alone

Other group

Description:

Valsartan alone

Treatment:

Drug: Valsartan

Hydrochlorothiazide 25 mg alone

Other group

Description:

Hydrochlorothiazide alone

Treatment:

Drug: Hydrochlorothiazide

Valsartan 320 mg + Hydrochlorothiazide 25 mg

Other group

Description:

Concomitant administration of valsartan 320 mg + Hydrochlorothiazide 25 mg

Treatment:

Drug: Valsartan/Hydrochlorothiazide

Valsartan / Hydrochlorothiazide 320 mg/25mg

Other group

Description:

Fixed dose combination of valsartan 320 mg + Hydrochlorothiazide 25 mg

Treatment:

Drug: Valsartan/Hydrochlorothiazide