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Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide (PKLH)

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. Identifier: NCT01858623
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : May 27, 2013
Information provided by (Responsible Party):
Sally Helmy, PhD, CPHQ, Damanhour University

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

Condition or disease Intervention/treatment Phase
Healthy Normotensive Participants Drug: Losartan/hydrochlorothiazide Drug: Losartan Drug: Hydrochlorothiazide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Losartan / Hydrochlorothiazide100 mg/25mg
Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination
Drug: Losartan/hydrochlorothiazide
Losartan 100 mg
Losartan 100 mg alone
Drug: Losartan
hydrochlorothiazide 25 mg
hydrochlorothiazide 25 mg alone
Drug: Hydrochlorothiazide

Primary Outcome Measures :
  1. Heart rate [ Time Frame: Participants will be followed for the duration of study, an expected average of 5 weeks. ]
  2. Blood pressure [ Time Frame: Participants will be monitored for the duration of study, an expected average of 5 weeks. ]
  3. Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide [ Time Frame: At the end of the study, after collection of all blood samples, an expected average of 4 weeks ]
  4. Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide [ Time Frame: At the end of the study, after collection of all blood samples, an expected average of 4 weeks ]

Information from the National Library of Medicine

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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
  • 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

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Responsible Party: Sally Helmy, PhD, CPHQ, Lecturer of Pharmaceutics, Faculty of Pharmacy, Damanhour University Identifier: NCT01858623     History of Changes
Other Study ID Numbers: PPT5
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013
Keywords provided by Sally Helmy, PhD, CPHQ, Damanhour University:
Healthy Normotensive Participants
Fixed dose combination
Additional relevant MeSH terms:
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Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators