A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

An Open-label, Multiple-dosing, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938197

Enrollment

Registered

2009-07-13

Start date

2009-06-30

Completion date

2009-08-31

Last updated

2009-10-08

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

Conditions

Essential Hypertension

Keywords

Fimasartan, Drug interaction

Brief summary

To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers

Interventions

DRUGFimasartan

Fimasartan (1d\ 7d) Amlodipine (12d\ 14d) Fimasartan + Amlodipine(15d\ 21d)

DRUGAmlodipine

Amlodipine (1d\ 10d) Amlodipine (25d\ 27d) Fimasartan + Amlodipine(28d\ 34d)

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* age: 20 - 40 years * sex: male * body weight: greater than 55 kg * written informed consent

Exclusion criteria

* known allergy to Fimasartan and amlodipine * existing cardiac or hematological diseases * existing hepatic and renal diseases * existing gastrointestinal diseases * acute or chronic diseases which could affect drug absorption or metabolism * history of any serious psychological disorder * positive drug or alcohol screening * smokers of 10 or more cigarettes per day 3 month ago * participation in a clinical trial during the last 2 months prior to the start of the study

Design outcomes

Primary

Measure	Time frame
AUCss, Cmax,ss, Tmax,ss, CLss/F	Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day

Countries

South Korea

Outcome results

None listed

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