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

Boryung

Status and phase

Completed

Phase 1

Conditions

Hypertension, Hyperlipidemia

Treatments

Drug: Fimasartan, Atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02994745

BR-FAVC-CT-102

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.