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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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.