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

Phase 1

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide

• Registration Number: NCT01198249
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2011-02
• Status Verified: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-25
• Last Update Posted: 2011-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HCTZ	multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide	-
mlodipine and Losartan and HCTZ	multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide	-
amlodipine monotherapy	multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide	-
losartan monotherapy	multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide	-

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of