Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Interventions

  • Drug: Losartan/hydrochlorothiazide
  • Drug: Losartan
  • Drug: Hydrochlorothiazide

Arms, Groups and Cohorts

  • Other: Losartan / Hydrochlorothiazide100 mg/25mg
    • Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination
  • Other: Losartan 100 mg
    • Losartan 100 mg alone
  • Other: hydrochlorothiazide 25 mg
    • hydrochlorothiazide 25 mg alone

Clinical Trial Outcome Measures

Primary Measures

  • Heart rate
    • Time Frame: Participants will be followed for the duration of study, an expected average of 5 weeks.
  • Blood pressure
    • Time Frame: Participants will be monitored for the duration of study, an expected average of 5 weeks.
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Damanhour University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sally Helmy, PhD, CPHQ, Lecturer of Pharmaceutics, Faculty of Pharmacy – Damanhour University

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