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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198249
• Other study ID #: 4-2010-0295
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2010
• Last updated: March 25, 2011
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of,