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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yonsei University
• Treatments: Amlodipine; Hydrochlorothiazide; Losartan

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