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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01198249

Enrollment

Registered

2010-09-10

Start date

2010-09-30

Completion date

2011-03-31

Last updated

2011-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

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.

Interventions

DRUGmultiple 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026