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OpenTrials
Completed

NCT Number: NCT01198249

Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension

This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult subjects 20-50 years of age
  • Above 55Kg and within ±20% ideal body weight
  • Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) < 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) < 100mmHg
  • Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
  • Subjects who wrote informed consent

Exclusion criteria

  • Subjects who are suspected to have acute disease
  • Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
  • Subjects who have gastrointestinal history
  • Subjects whose heartrate is less than 60
  • Subject who suspected to orthostatic hypotension
  • Subjects who have clinically significant allergy disease
  • Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
  • Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
  • Subjects who have past history of drug abuse and positive in drug screening test
  • Subjects who donate whole blood within 60 days and platelet within 30days.
  • Subjects taking St John's wort or CYP inhibitor and inducer

Treatment and study plan

multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide

Drug

amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Randomized, Open Label, Multiple Dose, Crossover Study to Investigate Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide(HCTZ) in Subjects With (Pre)Hypertension

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2010
Registry last updated
Mar 28, 2011

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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