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
1 other identifier
interventional
23
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 28, 2011
March 1, 2011
5 months
September 8, 2010
March 25, 2011
Conditions
Study Arms (4)
amlodipine monotherapy
EXPERIMENTALlosartan monotherapy
EXPERIMENTALHCTZ
EXPERIMENTALmlodipine and Losartan and HCTZ
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Yong Chung, MD, Ph.D
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 10, 2010
Study Start
September 1, 2010
Primary Completion
February 1, 2011
Study Completion
March 1, 2011
Last Updated
March 28, 2011
Record last verified: 2011-03