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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01198249
First received: September 8, 2010
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Enrollment: 23
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amlodipine monotherapy Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
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
Experimental: losartan monotherapy Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
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
Experimental: HCTZ Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
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
Experimental: mlodipine and Losartan and HCTZ Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01198249

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Jae-Yong Chung, MD, Ph.D Severance Hospital
  More Information

No publications provided

Responsible Party: Kyung-Mi Park / Director, Hanmi Pharmaceutial Co., Ltd.
ClinicalTrials.gov Identifier: NCT01198249     History of Changes
Other Study ID Numbers: 4-2010-0295
Study First Received: September 8, 2010
Last Updated: March 25, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Hydrochlorothiazide
Losartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014