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

An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02995720

Enrollment

Registered

2016-12-16

Start date

2016-08-26

Completion date

2017-05-30

Last updated

2017-08-10

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

Conditions

Hypertension, Hyperlipidemia

Brief summary

An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.

Interventions

DRUGFimasartan/Amlodipine combination drug, Rosuvastatin

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

* 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 (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin	0~72 hour after medication
AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin	0~72 hour after medication

Outcome results

None listed

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