CKD-337 Drug Interaction Study

NCT02066207 | Completed Phase 1

• 1 other identifier: 146DDI13024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.

Conditions

Dyslipidemia (Fredrickson Type Ⅱa); Dyslipidemia (Fredrickson Type Ⅱb)

Outcome Measures

Primary Outcomes (1)

• AUCt, Cmax,ss of fenofibric acid and atorvastatin

  0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Secondary Outcomes (1)

• Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation

  0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h

Study Arms (3)

Fenofibrate

EXPERIMENTAL

Subjects received Fenofibrate

Drug: Fenofibrate

Atorvastatin

EXPERIMENTAL

Subjects received Atorvastatin

Drug: Atorvastatin

Fenofibrate and Atorvastatin

EXPERIMENTAL

Subjects received Fenofibrate and Atorvastatin

Drug: Fenofibrate; Drug: Atorvastatin

Interventions

Fenofibrate DRUG

Fenofibrate; Fenofibrate and Atorvastatin

Atorvastatin DRUG

Atorvastatin; Fenofibrate and Atorvastatin

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy male volunteer between 19 and 55 years old.
• BMI between 18.5 and 27.
• Able to participate in the entire trial
• Signed the informed consent form prior to study participation.

You may not qualify if:

• Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
• sit SBP \< 100mmHg or sit SBP ≥ 150mmHg or sit DBP \< 70mmHg or sit DBP ≥ 100mmHg
• Have acute infection history within 14 days
• Have a allergic disease of need to treat
• Have hypersensitivity reactions history for IP or any specific drugs.
• AST, ALT or Total bilirubin \> UNL \* 1.5
• Estimated GFR \< 60 ml/min
• Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• A heavy smoker (cigarette \> 10 cigarettes per day)
• A heavy alcohol consumer (alcohol \> 140g/week)
• A heavy grapefruit consumer (more than 1cup per a day)
• Have a history of drug abuse or showed a positive for urine drug test.
• Administrated IP within 60 days prior to screening
• Rhabdomyolysis include of having a history or family history of genetic muscle diseases
• Positive for HIV antibody, HBsAg, HCV antibody test

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Fenofibrate; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Wooseong Huh, M.D., Ph.D.

  Samsung Medical Center

  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: February 16, 2014
• First Posted: February 19, 2014
• Study Start: March 18, 2014
• Primary Completion: April 7, 2014
• Study Completion: May 29, 2014
• Last Updated: August 8, 2017

Record last verified: 2014-03

Locations

KR (1)