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

September 8, 2010
March 25, 2011
September 2010
February 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01198249 on ClinicalTrials.gov Archive Site
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Not Provided
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Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Essential Hypertension
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: amlodipine monotherapy
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
  • Experimental: losartan monotherapy
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
  • Experimental: HCTZ
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
  • Experimental: mlodipine and Losartan and HCTZ
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
March 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01198249
4-2010-0295
No
Kyung-Mi Park / Director, Hanmi Pharmaceutial Co., Ltd.
Yonsei University
Not Provided
Principal Investigator: Jae-Yong Chung, MD, Ph.D Severance Hospital
Yonsei University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP