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.

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

Study Overview

• Status: Completed
• Conditions: Hypertension, Hyperlipidemia
• Intervention / Treatment: Drug: Fimasartan, Atorvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A fixed dose combination group; A fixed dose combination of Fimasartan/Atorvastatin	Drug: Fimasartan, Atorvastatin
Active Comparator: Co-administration group; Co-administration of Fimasartan and Atorvastatin	Drug: Fimasartan, Atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2016
• Primary Completion (Actual): February 21, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: BR-FAVC-CT-102