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Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

Information source: Damanhour University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Normotensive Participants

Intervention: Losartan/hydrochlorothiazide (Drug); Losartan (Drug); Hydrochlorothiazide (Drug)

Phase: N/A

Status: Completed

Sponsored by: Damanhour University

Summary

This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Heart rate

Blood pressure

Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide

Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- At least 18 years old and not more than 45 healthy male volunteers

- Who had passed all the screening parameters

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

- The use of any prescription drug within the previous month or use of any

over-the-counter medication 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

Locations and Contacts

Additional Information

Starting date: February 2013
Last updated: May 24, 2013

Page last updated: August 23, 2015

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