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

NCT02994745 | Completed Phase 1

• 1 other identifier: BR-FAVC-CT-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension, Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin

  0~48 hours after medication

• 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

Study Arms (2)

A fixed dose combination group

EXPERIMENTAL

A fixed dose combination of Fimasartan/Atorvastatin

Drug: Fimasartan, Atorvastatin

Co-administration group

ACTIVE COMPARATOR

Co-administration of Fimasartan and Atorvastatin

Drug: Fimasartan, Atorvastatin

Interventions

Fimasartan, Atorvastatin DRUG

A fixed dose combination group; Co-administration group

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

fimasartan; Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 16, 2016
• Study Start: December 23, 2016
• Primary Completion: February 21, 2017
• Study Completion: August 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

KR (1)