A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337

NCT02651753 | Completed Phase 1

• 1 other identifier: 146BE15025
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (4)

• Atorvastatin AUCt

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

• Atorvastatin Cmax

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

• Fenofibric acid AUCt

  Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

• Fenofibric acid Cmax

  Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

Secondary Outcomes (17)

• Atorvastatin AUCinf

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

• Atorvastatin Tmax

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

• Atorvastatin t1/2

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

• Atorvastatin CL/F

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

• Atorvastatin Vd/F

  Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

Study Arms (2)

A

EXPERIMENTAL

Period 1: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions. Period 2: Test drug(CKD-337), 1 capsule administered under fed conditions.

Drug: Lipitor + Lipidil supra; Drug: CKD-337

B

EXPERIMENTAL

Period 1: Test drug(CKD-337), 1 capsule administered under fed conditions. Period 2: Reference drug (Lipitor+ Lipidil supra), 2 tablets administered under fed conditions.

Drug: Lipitor + Lipidil supra; Drug: CKD-337

Interventions

Lipitor + Lipidil supra DRUG

Reference Drug: Lipitor + Lipidil supra

Also known as: Lipitor(Atorvastatin calcium trihydrate 21.70mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)

A; B

CKD-337 DRUG

Test Drug: CKD-337

Also known as: CKD-337(Atorvastatin calcium trihydrate 21.70mg+Cholinfe fenofibrate 178.8mg/capsule)

A; B

Eligibility Criteria

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

You may qualify if:

• Healthy male older than 19 years at the time of screening
• BMI 17.5\~30.5 kg/m2 and body weight more than 55kg
• Subject who is no chronic disease, no symptoms or pathological findings
• Suitable subject who is determined by laboratory tests(hematology test, blood chemistry, urinalysis test) according to the characteristics of the drug and ECG test at the time of screening
• Subject who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent

You may not qualify if:

• Subject who has a history of hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases that is clinically significant and who has a following history 1) Gallbladder disease including cholelithiasis, severe hepatic impairment 2) Acute/chronic pancreatitis due to hypertriglyceridemia 3) Pulmonary embolism or interstitial lung disease 4) Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 5) Hypoalbuminemia 6) Alcoholics 7) Predisposition to rhabdomyolysis
• Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
• Subject who has hypersensitivity to the drug composition containing choline fenofibrate, fenofibrate or atorvastatin, and other drug(aspirin, fenofibrate series, antibiotic and so on)
• The following clinical significant findings at the time of screening
• QTc \> 450ms
• PR interval \> 200msec
• QRS duration \> 120msec
• The following results in the clinical laboratory tests
• CPK \> 2 x upper limit of normal range
• Liver function test (AST, ALT, ALP, Total bilirubin, γ-GT) \> 2 x upper limit of normal range
• eGFR(estimated GFR) \< 60 mL/min/1.73m2
• Systolic blood pressure ≥ 160mmHg or ≤ 100mmHg, Diastolic blood pressure ≥ 95mmHg or ≤ 60mmHg at the time of screening
• History of drug abuse or a positive reaction for drug abuse at the screening test for urine
• Taking ETC, oriental medicine within 2 weeks and OTC, vitamin within 1 week before the first dosing
• Taking the medication involved in other clinical trials within 3 months before the first dosing

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

MeSH Terms

Conditions

Dyslipidemias

Interventions

Atorvastatin; Fenofibrate; Tablets

Condition Hierarchy (Ancestors)

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; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Dosage Forms; Pharmaceutical Preparations

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: January 8, 2016
• First Posted: January 11, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share