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OpenTrials
Completed

NCT Number: NCT01858623

Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

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

Completed

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Key information

Conditions

Healthy Normotensive Participants

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan/hydrochlorothiazide

Drug

Losartan

Drug

Hydrochlorothiazide

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Acronym: PKLH

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 21, 2013
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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