A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02566187

Enrollment

Registered

2015-10-02

Start date

2015-08-31

Completion date

2015-10-31

Last updated

2016-02-25

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

Conditions

Hyperlipidemia, Hypertension

Brief summary

A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.

Interventions

DRUGFimasartan/Atorvastatin Combination Tablet

DRUGFimasartan

DRUGAtorvastatin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* a Healthy male subject, aged 19- 50 years

Exclusion criteria

* History of clinically significant hypersensitivity to study drug, any other drug * Hypotension or hypertension * Active liver disease * History of gastrointestinal disease * History of excessive alcohol abuse * Participation in any other study within 3 months

Design outcomes

Primary

Measure	Time frame
Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin	0~48 hour after medication
Area under the curve(AUCt) of Fimasartan and Atorvastatin	0~48 hour after medication

Countries

South Korea

Outcome results

None listed

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