CKD-337(2) Drug-drug Interaction Study

NCT02422030 | Completed Phase 1

• 1 other identifier: 146DDI14030
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic interaction between Atorvastatin and Fenofibric acid.

Conditions

Healthy

Keywords

Male Volunteers

Outcome Measures

Primary Outcomes (2)

• Atorvastatin and Fenofibric acid AUCτ

  1D\~7D 19points, 1D\~7D 18points, 1D\~7D 20points

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

• Atorvastatin and Fenofibric acid Css,max

  1D\~7D 19points, 1D\~7D 18points, 1D\~7D 20points

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

Secondary Outcomes (4)

• Atorvastatin and Fenofibric acid Css,min

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

• Atorvastatin and Fenofibric acid Css,av

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

• 2-hydroxyatorvastatin AUCτ

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

• 2-hydroxyatorvastatin Css,max

  predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours post-dose, an expected average of 6weeks

Study Arms (6)

Group1: TreatmentA+TreatmentB+TreatmentC

EXPERIMENTAL

TreatmentA: Atorvastatin 40m\*1T/day, TreatmentB: Fenofibric acid 135mg\*1Cap/day, TreatmentC: Atorvastatin 40m\*1T/day and Fenofibric acid 135mg\*1Cap/day. Each treatment period was separated by a washout period of at least 8days.

Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg

Group2: TreatmentC+TreatmentA+TreatmentB

EXPERIMENTAL

TreatmentA: Atorvastatin 40m\*1T/day, TreatmentB: Fenofibric acid 135mg\*1Cap/day, TreatmentC: Atorvastatin 40m\*1T/day and Fenofibric acid 135mg\*1Cap/day. Each treatment period was separated by a washout period of at least 8days.

Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg

Group3: TreatmentB+TreatmentC+TreatmentA

EXPERIMENTAL

TreatmentA: Atorvastatin 40m\*1T/day, TreatmentB: Fenofibric acid 135mg\*1Cap/day, TreatmentC: Atorvastatin 40m\*1T/day and Fenofibric acid 135mg\*1Cap/day. Each treatment period was separated by a washout period of at least 8days.

Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg

Group4: TreatmentC+TreatmentB+TreatmentA

EXPERIMENTAL

TreatmentA: Atorvastatin 40m\*1T/day, TreatmentB: Fenofibric acid 135mg\*1Cap/day, TreatmentC: Atorvastatin 40m\*1T/day and Fenofibric acid 135mg\*1Cap/day. Each treatment period was separated by a washout period of at least 8days.

Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg

Group5: TreatmentB+TreatmentA+TreatmentC

EXPERIMENTAL

TreatmentA: Atorvastatin 40m\*1T/day, TreatmentB: Fenofibric acid 135mg\*1Cap/day, TreatmentC: Atorvastatin 40m\*1T/day and Fenofibric acid 135mg\*1Cap/day. Each treatment period was separated by a washout period of at least 8days.

Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg

Group6: TreatmentA+TreatmentC+TreatmentB

EXPERIMENTAL

TreatmentA: Atorvastatin 40m\*1T/day, TreatmentB: Fenofibric acid 135mg\*1Cap/day, TreatmentC: Atorvastatin 40m\*1T/day and Fenofibric acid 135mg\*1Cap/day. Each treatment period was separated by a washout period of at least 8days.

Drug: Lipitor Tab. 40mg; Drug: Trilipix 135mg

Interventions

Lipitor Tab. 40mg DRUG

Also known as: Atorvastatin 40mg

Group1: TreatmentA+TreatmentB+TreatmentC; Group2: TreatmentC+TreatmentA+TreatmentB; Group3: TreatmentB+TreatmentC+TreatmentA; Group4: TreatmentC+TreatmentB+TreatmentA; Group5: TreatmentB+TreatmentA+TreatmentC; Group6: TreatmentA+TreatmentC+TreatmentB

Trilipix 135mg DRUG

Also known as: Fenofibric acid 135mg

Group1: TreatmentA+TreatmentB+TreatmentC; Group2: TreatmentC+TreatmentA+TreatmentB; Group3: TreatmentB+TreatmentC+TreatmentA; Group4: TreatmentC+TreatmentB+TreatmentA; Group5: TreatmentB+TreatmentA+TreatmentC; Group6: TreatmentA+TreatmentC+TreatmentB

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy man older than 19 years at the time of screening.
• BMI more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 55kg
• Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
• Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
• Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
• Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.

You may not qualify if:

• Subject who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
• Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
• Showing the value that corresponds to following laboratory parameters: AST or AST or CK \> 2\* upper limit of normal range.
• Alcohol \> 210g/week, within 6 months prior to the screening.
• Taking the medication involved in other clinical trials within two months before the first dose medication characters.
• Sitting Systolic Blood Pressure ≥ 140 mmHg, Diastolic Blood Pressure ≥ 90 mmHg at the time of screening.
• History of alcohol or drug abuse, within 1 year
• Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
• Smoker (\> 20cigarettes/day)
• Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
• Subject who done the whole blood donation within two months or component blood donation within 1 month within 1 month prior to the first dosing.
• Subject who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
• Subject with serious history of hypersensitivity or allergy to investigational product.
• Active liver disease.
• Muscle disease.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Deokjin-gu, Jeonju-si, Jeollabuk-do, 561-712, South Korea

Location

MeSH Terms

Interventions

Atorvastatin; Fenofibrate; fenofibric acid

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Min Gul Kim

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

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: March 25, 2015
• First Posted: April 21, 2015
• Study Start: March 17, 2015
• Primary Completion: March 22, 2015
• Study Completion: April 30, 2015
• Last Updated: August 8, 2017

Record last verified: 2015-03

Locations

KR (1)