A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.

A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02994745

Enrollment

Registered

2016-12-16

Start date

2016-12-23

Completion date

2017-08-31

Last updated

2018-01-18

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

Conditions

Hypertension, Hyperlipidemia

Brief summary

The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.

Detailed description

This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.

Interventions

DRUGFimasartan, Atorvastatin

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 aged 19-50 years * Body weight is over 55kg and BMI 18 \ 27(kg/m2). * A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol. * A subject who is eligible according to investigator's assessment

Exclusion criteria

* History or presence of clinically significant medical or psychiatric condition or disease. * History of gastrointestinal disease and resection * Hypersensitivity to ingredient of investigational product(IP) and other medication, food. * Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption. * A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months. * Positive results for serum examination(HIV, B and C viral test, Syphilis). * Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening. * Participation in any other study within 3months. * History of whole blood donation within 2months and Apheresis 2 weeks.

Design outcomes

Primary

Measure	Time frame
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin	0~48 hours after medication
Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin	0~48 hours after medication

Countries

South Korea

Outcome results

None listed

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