A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02569814

Enrollment

100

Registered

2015-10-07

Start date

2015-09-30

Completion date

2015-12-31

Last updated

2016-02-24

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 Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects.

Interventions

DRUGFimasartan/Amlodipine/Rosuvastatin

DRUGFimasartan/Amlodipine

DRUGRosuvastatin

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
Cmax of Fimasartan, Amlodipine and Rosuvastatin	0~144 hour after medication
AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin	0~144 hour after medication

Countries

South Korea

Outcome results

None listed

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